Site Quality Leader

Associate Director RA & QA

Chemist Data Reviewer

Mold MPDE Engineer

Mechanical Engineer

120264/120265 Staff Mfg & Process DVL Engineer

Role Description: <ul><li>The Site Quality Leader is responsible for the administration, supervision, and development of the Wilsonville Quality Assurance and Quality Engineering functions.&nbsp;</li><li>This position is responsible for ensuring full compliance to the regulatory requirements of 21 CFR 820, ISO13485, MDR and other applicable regulations including production and process controls.&nbsp;</li><li>The Site Quality Leader will report to the Global Head of Quality Operations.</li></ul> Responsibilities: <ul><li>Ensure that Material Review Boards are in place to ensure products are appropriately dispositioned within a timely manner, while ensuring appropriate corrective and preventive actions are initiated and regulatory requirements are met.</li></ul>&nbsp;Develop and implement systems to assure that development as well as production teams receive support in the following areas: <ul><li>Quality planning, including inspection techniques and sampling methods</li><li>Statistical Analysis</li><li>Application of required regulatory standards</li></ul> Develop and implement procedures and systems to assure product manufactured for human use meets design and functional specifications. These systems are to include as a minimum: <ul><li>Delivery of raw materials and components</li><li>Manufactured devices and equipment</li><li>Documentation associated with these functions</li><li>Develop, track, and report on the following administrative systems:</li><li>Department metrics</li><li>Department objectives</li><li>Personnel development and training</li><li>Support regulatory agency and customer quality audits.</li><li>Ensure the conformity of the components and products are appropriately checked in accordance with the Quality Management System before release.</li><li>Responsible for assisting and training associates in concepts of probability and statistics.</li><li>Responsible for failure appraisal and analysis (internal and external).</li><li>Authority to place products or processes on hold.</li><li>Design and develop forms and instructions for recording, evaluating, and reporting quality data.</li><li>Corrective and Preventive Action program</li><li>Based on operational/quality requirements, assist in test equipment selection and validation.</li><li>Utilize formal problem solving techniques to resolve product and/or process related issues.</li><li>As required, lead cross-functional teams to support resolution of product and/or process related issues or objectives.</li><li>Work with suppliers of both raw materials and components, to improve product quality and/or resolve quality issues.</li><li>Be innovative, knowledgeable and intensely committed to ensure that every product and service we supply conforms to FDA and Quality System Regulations..</li></ul> Requirements: <ul><li>Bachelors Degree with a scientific or engineering emphasis.</li><li>ASQ Certified Quality Engineer recommended. Six Sigma Green/Black belt recommended.</li><li>7-10 years experience in a related regulatory environment.</li><li>Experience should include positions at senior levels within the medical device organizations.</li></ul>

Role Description: <ul><li>The Associate Director – Regulatory Affairs (CA) will lead the development and execution of regulatory strategies to support the timely approval, lifecycle management, and commercialization of generic pharmaceutical products in Canada. </li><li>The role will focus heavily on Abbreviated New Drug Submissions (ANDS) and Supplemental ANDS filings, while acting as the primary interface with Health Canada for regulatory discussions, clarifications, and negotiations.</li><li>This position plays a critical strategic role in new product development, portfolio expansion, and in-licensing evaluation, ensuring all regulatory activities align with Health Canada requirements, corporate objectives, and market access timelines.</li><li>The Director will also support portfolio maximization (PMX) initiatives, identify regulatory opportunities, and oversee a small regulatory team.</li></ul> Responsibilities: Regulatory Strategy &amp; Leadership <ul><li>Develop and implement regulatory strategies for ANDS submissions to Health Canada that maximize probability of approval and accelerate time to market.</li><li>Provide strategic regulatory guidance during product selection and development phases, including formulation, bioequivalence, and labeling strategy.</li><li>Ensure regulatory considerations are integrated into R&amp;D, clinical, CMC, and commercial planning.</li><li>Advise senior leadership on Canadian regulatory landscape, evolving guidelines, and approval pathways.</li><li>Lead regulatory planning for first-to-file, complex generics, and niche opportunities where applicable.</li></ul> Health Canada Engagement &amp; Regulatory Submissions <ul><li>Serve as the primary liaison with Health Canada, maintaining professional and proactive relationships with regulatory authorities.</li><li>Lead preparation and submission of: o Abbreviated New Drug Submissions (ANDS)</li><li>Supplemental ANDS (SANDS)</li><li>Notifiable Changes</li><li>Post-approval regulatory filings</li><li>Manage Health Canada deficiency responses, clarification requests, and review cycles.</li><li>Coordinate cross-functional teams to ensure high-quality regulatory dossiers</li><li>Represent the company in Health Canada meetings, scientific advice discussions, and regulatory negotiations.</li><li>Track and interpret Health Canada guidance updates, policy changes, and regulatory precedents affecting generic drug approvals.</li></ul> In-Licensing &amp; Regulatory Due Diligence <ul><li>Conduct regulatory due diligence for potential in-licensing and partnership opportunities.</li><li>Evaluation of regulatory pathways and submission feasibility</li><li>Data package completeness</li><li>Bioequivalence strategy</li><li>Intellectual property and exclusivity considerations</li><li>Estimated approval timelines and risks</li><li>Provide regulatory risk assessments and strategic recommendations to senior management during deal evaluation.</li><li>Support technology transfer and regulatory integration of licensed products into the company’s Canadian portfolio.</li></ul> Portfolio Management &amp; Lifecycle Optimization <ul><li>Support portfolio maximization (PMX) initiatives, including o Label expansions</li><li>New strengths and dosage forms</li><li>Site transfers</li><li>Manufacturing changes</li><li>Competitive lifecycle strategies</li><li>Identify regulatory opportunities to extend product lifecycle or improve market competitiveness.</li><li>Partner with commercial, market access, and supply chain teams to align regulatory activities with business objectives.</li></ul> Cross-Functional Collaboration <ul><li>Work closely with internal teams including o R&amp;D / Formulation Development</li><li>Clinical &amp; Bioequivalence</li><li>Quality Assurance / Quality Control</li><li>CMC / Manufacturing</li><li>Intellectual Property</li><li>Business Development</li><li>Provide regulatory input during product development milestones and technical reviews.</li><li>Ensure regulatory compliance with Health Canada, ICH, and global regulatory standards.</li></ul> Team Leadership &amp; Development <ul><li>Lead, mentor, and develop 1–3 regulatory associates/managers.</li><li>Oversee work allocation, submission timelines, and performance development.</li><li>Build a high-performance regulatory function capable of managing increasing submission volume.</li><li>Promote a culture of accountability, quality, and regulatory excellence.</li></ul> Requirements: Education &amp; Experience <ul><li>Advanced degrees in Pharmacy, Life Sciences, Pharmacology, Regulatory Affairs, or related discipline.</li><li>Regulatory certification (e.g., RAC) is considered an asset.</li><li>15–20 years of regulatory affairs experience within the pharmaceutical industry.</li><li>Extensive experience with Canadian regulatory submissions, particularly:</li><li>ANDS</li><li>SANDS</li><li>eCTD filings</li><li>Demonstrated experience interacting directly with Health Canada.</li><li>Strong understanding of Generic drug approval pathways</li><li>Bioequivalence requirements</li><li>CMC regulatory expectations</li><li>Experience supporting business development or in-licensing regulatory evaluations.</li><li>Previous team leadership or mentoring experience preferred.</li></ul> Core Competencies <ul><li>Strategic Thinking Ability to translate regulatory requirements into business-focused strategies that accelerate approvals and strengthen the company’s competitive position.</li><li>Regulatory Expertise Deep knowledge of Health Canada regulatory frameworks, ANDS requirements, and generic drug approval processes.</li><li>Stakeholder Influence Proven ability to engage effectively with regulatory authorities, internal leadership, and external partners</li><li>Physical Requirements</li></ul> Physical &amp; mental requirements: <ul><li>Business travel (15% of time), driving as part of work responsibilities.</li></ul>

Job Summary: <ul><li>This position is dedicated to the review, verification, and assessment of analytical data generated within the Quality Control laboratory.&nbsp;</li><li>The role ensures that all laboratory documentation meets cGMP, regulatory, and internal quality standards.&nbsp;</li><li>Responsibilities do not include performing laboratory testing, operating instruments, or releasing materials or products.</li></ul> Responsiblities: <ul><li>Review complete analytical data packages generated from a wide range of QC laboratory instrumentation, including HPLC, UPLC, GC, UV?Vis, FT?IR, Dissolution, X?Ray Diffraction (XRD), pH meters, Karl Fischer, ICP-MS, and other compendial or platform - specific systems.</li><li>Verify calculations, chromatographic integrations, peak assignments, system suitability criteria, and instrument audit trails across software platforms such as Empower, ChemStation, LabSolutions, ICP?MS data systems, and dissolution software.</li><li>Assess data for compliance with approved analytical methods, compendial requirements, SOPs, and cGMP expectations, ensuring consistency across diverse analytical techniques.</li><li>Evaluate raw data outputs such as chromatograms, spectra (UV, IR), dissolution profiles, XRD patterns, elemental analysis reports, pH logs, and mass spectrometry data for accuracy and scientific soundness.</li><li>Identify discrepancies, atypical trends, integration anomalies, missing data, or potential data integrity concerns and escalate findings promptly.</li><li>Confirm that all raw data, worksheets, logbooks, electronic records, and metadata comply with ALCOA+ principles and meet internal documentation standards.</li><li>Review LIMS entries for accuracy, completeness, and proper linkage to supporting raw data and metadata.</li><li>Ensure instrument-specific parameters (e.g., wavelength accuracy for UV, calibration curves for ICP?MS, dissolution run conditions, GC column performance) are appropriately documented and meet acceptance criteria.</li></ul> Requirements: Education &amp; Experience: <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>Bachelor of Science Degree in chemistry, chemical engineering or related field with 4+ years’ relevant analytical laboratory experience OR</li><li>Master’s Degree in above disciplines with 2+ years’ relevant analytical lab experience</li></ul> Knowledge: <ul><li>Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports</li><li>Full proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.</li><li>Thorough knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS</li><li>Has demonstrated competence in conducting chemical analyses</li><li>Strong knowledge of wet chemistry techniques</li><li>Competency in Microsoft Office Suite</li></ul> Skills &amp; Abilities: <ul><li>Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information, reporting to management</li><li>Ability to display and analyze data in a logical manner</li><li>Ability to critically review, analyze data, interpret information, and draw conclusions from relevant or missing information</li><li>Ability to display and analyze data in a logical manner</li><li>Strong verbal and written communication skills as well as good computer skills</li><li>Strong attention to details and accurate record keeping</li><li>Establish and maintain cooperative working relationships with others</li><li>Solid organizational skills</li><li>Ability to coach less senior staff and develop laboratory skills and ability</li><li>Ability to take initiative, set priorities and follow through on assignments</li></ul> Physical Requirements: <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel.&nbsp;</li><li>Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.</li><li>Specific visions abilities are required by this job include close vision and color vision</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods</li></ul>

Responsibilities: <ul><li>Responsible for Design and Developmeant of Mold tooling and Processes to support new product development.</li><li>Own DFM, PFMEA to optimize product design, process design and tooling design, Realizes sample tooling and product samples.</li><li>Determines the most suitable manufacturing concepts related to planned manufacturing quantities, quality requirements and manufacturing location.</li><li>Ensure molds and processes are designed to be capable of producing good quality products efficiently and effectively at the lowest possible cost.</li><li>Ensure projects are completed in a timely manner and properly transferred to manufacturing upon First Article approval complete with documentation.</li><li>Provide cost estimations for new mold tooling and processes.</li><li>Work within a cross-functional team consisting of various process experts.</li><li>Integrate feedback and lessons learned into new molds and molding processes.</li><li>Collaborate with global experts to update and continuously improve operational standards with regard to plastic injection molding.</li><li>Study or Introduce new technologies into process designs to maximize yield and efficiency.</li></ul> Requirements: <ul><li>Degree or Diploma in mechanical/production engineering.</li><li>More than 8 years Mold design, Process and Troubleshooting knowledge / experience.</li><li>Strong knowledge of tool fabrication, tool-steel application/selection, heat treating, and plating/coating.&nbsp;</li><li>Strong knowledge of injection molding processes (Injection, Insert-molding, two-shot, etc.).</li><li>Strong understanding of plastic, injection machine, auxiliary equipment (strip feed, camera, etc).</li><li>Good at Mold flow simulation and analysis.</li><li>Familiar with BTI 5-Step process, and Knowledge of SIM (Scientific Injection Molding).</li><li>Understand tolerance calculations and Geometric Dimensioning and Tolerancing.</li><li>Good project management skill – Ability to work on several projects at once.</li><li>Effective prepare and present Technical knowledge within a group setting.</li><li>Willingness to travel (25% travel).</li><li>Ability to effectively communicate in English – Written and Spoken.</li></ul>

Responsibilities: <ul><li>Product development – PDCA</li><li>Understand customer requirements and transfer the customer requirement to product feature.</li><li>Working together with related engineer on concept design and validation test.</li><li>Design mechanical module and complete the testing of new product.</li><li>According to analysis of new product’s characteristics, solve the problem while occurred</li><li>during testing product and ensure new product’s research go on smoothly.</li><li>Equipment and documentation – Maintain and renew related engineering equipment. Compile and release the design/technical documentation.</li><li>Global Communication – Communication with cross functional teams including global engineering team (US, Europe), product manager, manufacturing team, automation manufacturing team and testing.</li><li>Communication and Reporting – Provide regular updates to team and management on program status, gaps, and where needed, provide potential solutions. Effective communication to internal and customer engineering teams.</li></ul> Requirements:&nbsp; Educational Degree: <ul><li>Bachelor or Master degree on ME, Physics or similar in process</li><li>At least 3 years mechanical design experience.</li></ul> :Mandatory Requirements: <ul><li>Good English skills, speaking and writing.</li><li>Knowledge of technical tools: e.g. CAD, CAE, Office, SAP.</li><li>Thorough knowledge of general engineering tools (LEAN or 6-sigma) such as DoE, FMEA, QFD, etc.</li><li>Deep technical knowledge on sensor products or related technology.</li><li>Analytical, structured, solution-oriented, and very precise way of working.</li></ul> Additional Requirements (optional): <ul><li>Utilize 2D/3D CAD software, e.g. CAD, SolidWorks</li><li>Experience in temperature sensing related knowledge.</li><li>Experience in statistical methods and data analysis in Minitab</li><li>Able to utilize scientific methods in problem solving</li><li>Experience in Multiphysics Simulation Tools like ANSYS</li><li>Experience in electronics design and (embedded) software programming is a plus</li></ul>

Responsibilities: <ul><li>Has strong impact in Advanced Manufacturing Technology Roadmap driven development projects.</li><li>Drives for excellence in existing Plating technologies and methods.</li><li>Strives to implement optimized or new manufacturing technologies to provide improved processes and tolerance control.</li><li>Act as a liaison between the Advance Manufacturing Process team and the manufacturing sites teams to collaborate with Product Development in the optimization of part and product designs for manufacturability, providing plating process expert knowledge and general knowledge of plating processes to realize product samples and prototypes.</li><li>Provides plating process expert knowledge and general knowledge and project management to liaise the Advance Manufacturing Process team and the manufacturing sites teams, deploying optimized or new plating processes to realize advanced manufacturing technology development projects.</li><li>Acts as the binding element between product development and advanced manufacturing &amp; process engineering, ensuring the effectiveness and efficiency of this critical interface.</li><li>Designs, develops, and qualifies plating processes in compliance with company EH&amp;S, quality and production standards, as well as recognized best in class and industry standards.</li><li>Documents all related processes in applicable company systems.</li><li>Supports supply chain to verify related suppliers’ compliance and capability.</li><li>Initiates and implements plating related programs to continuously improve quality, cost and cycle time.</li><li>Maintains and adheres to all appropriate specifications, regulatory and customer requirements.</li><li>Applies plating process expertise to resolve significant / unique / complex issues, where analysis of situations or data requires an in-depth evaluation of variable factors.</li><li>Exercises considerable latitude in determining objectives and approaches to assignment, performing work without appreciable direction.</li><li>Drives results primarily through collaboration and influence, not through direct reporting relationships.</li><li>Provides training and mentorship to other professional employees.</li><li>Provides measurable input to the objectives and goals of the department in support of the function and business unit strategies.</li></ul> Requirements: <ul><li>8 years working experience and above, Demonstrates injection molding process expertise (process optimization, capability, troubleshooting).</li><li>Deep technical knowledge of mold design, simulation (Moldflow), tool fabrication, scientific injection molding, molding processes (injection, insert, two-shot, etc.), molding equipment and ancillaries (FANUC, Engel).</li><li>Broad knowledge of stamping, plating, and assembly processes for connectors and sockets is desired.</li><li>NPI experience</li><li>at least 8 yrs related experience, but the candidates with good potential can be relaxed to 3-5 yrs of related working experience.</li><li>Relevant experience in connectors assembly.</li><li>Ability to design the fixtures independently and process development.</li><li>English is not required, but if the candidate can use English is plus.</li></ul>

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6 scientific editor Jobs found

Site Quality Leader

Associate Director RA & QA

Chemist Data Reviewer

Mold MPDE Engineer

Mechanical Engineer

120264/120265 Staff Mfg & Process DVL Engineer

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6 scientific editor Jobs found

Site Quality Leader

Associate Director RA & QA

Chemist Data Reviewer

Mold MPDE Engineer

Mechanical Engineer

120264/120265 Staff Mfg & Process DVL Engineer

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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