Site Quality Leader

Registered Operations Leader

Talent Acquisition Specialist

Data & ML Architect

Admin Support (Executive Assistant)

Sales Engineer, Mining

Associate Director RA & QA

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>

Responsibilities:&nbsp; <ul><li>Manage activities that support business results, revenue growth, client experience and efficiencies in practice.</li><li>Manage resources to achieve business results, including revenue and client acquisition targets.</li><li>Partner with Branch Manager to ensure advisor business plans are completed and marketing events are tracked and measured.</li><li>Assist advisors in servicing clients including preparing financial plans, conducting investment research and completing trades and transactions.</li><li>Prepare and summarize client meetings by scheduling and confirming meetings, crafting an agenda and summary of meeting, escorting clients to advisors office and providing follow-up. Prepare and ensure new business paperwork processes are successfully filled out.</li><li>Provide general administrative duties such as answering phones, processing reports, preparing correspondence, setup files, etc.</li><li>Build, manage, track and analyze reports and branch vitals.</li><li>Review advisor expense reports, branch P &amp; L, budgeting, reporting/correcting errors, identify and implement expense reduction opportunities.</li><li>Partner with Registered Principal to ensure compliance support is established and training needs are met.</li><li>Lead real estate and facilities initiatives.</li><li>Lead, coach, mentor and provide performance management for direct reports.</li><li>Partner with Senior Operations Leader and Regional Director of Operations to determine staffing needs; request, hire and allocate staff.</li><li>Conduct 1:1s with staff.</li></ul>﻿Requirements: <ul><li>Bachelors degree or equivalent.</li><li>5 - 7 years relevant experience required.</li><li>Previous successful supervisory experience including knowledge of HR policies and labor laws.</li><li>Excellent written and verbal communication skills; demonstrated ability to motivate team members to delivery results.</li><li>Ability to manage multiple priorities in a fast-paced environment with little or no supervision and strong organizational/time management skills.</li><li>Able to communicate with all levels within the organization.</li><li>Detail orientated, strong math, and analytical skills. Good organization and time management skills.</li><li>Process oriented and can work with a team. Proficient with standard business software applications.</li></ul>

Responsibilities: <ul><li>Manage the recruitment process end to end&nbsp;</li><li>Keep an overview of our recruitment needs via regular meetings with our Hiring Managers.</li><li>Design job descriptions and interview questions that reflect the position’s requirements and attract talent to Company</li><li>Determining selection criteria for the open positions, in line with the Company-culture and strategy.</li><li>Sourcing of potential candidates through different sourcing channels</li><li>Screening of potential candidates and planning interviews and assessments</li><li>Run regular updates to hiring managers</li><li>Will need to make presentations to senior management</li><li>Organize and lead feedback sessions and coordinate the hiring decision</li><li>Proposing employment offers in line with Company guidelines</li><li>Run reference checks when needed</li><li>Ensure that the recruitment process is efficient, effective and equitable.</li><li>Implement employer branding initiatives, both internally and externally</li><li>Organize and attend job fairs and recruitment events</li><li>Foster long-term relationships with candidates</li><li>Conduct Hiring manager and Brand ambassador workshops</li><li>Maintain strong connections with HR colleagues within Company to share best practices</li></ul> Requirements: <ul><li>Work experience as a recruiter with relevant experience with average of 7-10 years</li><li>Familiarity with social media, resume databases and professional networks</li><li>Experience with headhunting for mid to senior positions</li><li>Hands-on experience with full-cycle recruiting using interview techniques.</li><li>Experience with assessments is a plus but not a must</li><li>Strong communication skills</li><li>Good relationship building skills</li><li>Growth mindset and learning agility</li><li>Passion and desire to make a difference</li></ul>

Responsibilities: Strategic Leadership: <ul><li>Set the vision and direction for data and AI architecture for project and client.</li><li>Influence enterprise data and AI strategies, driving adoption of best practices in data, ML, and AI architecture.</li><li>Mentor and develop junior architects and engineers, fostering a culture of technical excellence and innovation.</li></ul> Architectural Excellence: <ul><li>Architect and design enterprise-scale data platforms and ML/AI solutions for scalability, reliability, and performance.</li><li>Define and enforce data and ML architecture standards, patterns, and governance frameworks for data pipelines, ML workflows, and analytics platforms.</li><li>Lead solution design for integrating data from diverse sources (streaming, batch, cloud, on-premises) using Azure, AWS, and GCP services.</li></ul> AI &amp; ML Leadership: <ul><li>Architect advanced Data Science, ML and AI solutions, including NLP, RAG LLM and Agentic AI systems.</li><li>Oversee the implementation of MLOps frameworks, ensuring robust deployment, monitoring, and lifecycle management of ML models.</li><li>Evaluate and recommend emerging AI/ML technologies and platforms, driving innovation in intelligent data products.</li><li>Provide Ethical AI leadership to ensure intelligent solutions are implemented when required and in safe methods.</li></ul> Technical Leadership: <ul><li>Oversee data modelling (e.g. medallion architecture), data governance, and quality frameworks. Implementing technical reviews and driving high standards.</li><li>Collaborate with engineering and DevOps teams to establish CI/CD and MLOps architectures using Azure DevOps, Kubernetes, and Terraform.</li><li>Guide the selection and implementation of visualization and analytics tools (Power BI, Tableau, PowerApps).</li></ul> Stakeholder Engagement: <ul><li>Engage with senior stakeholders to translate complex business requirements into technical solutions and strategic roadmaps.</li><li>Ensure all solutions meet security, compliance, and performance standards, and align with enterprise architecture principles.</li></ul> Innovation &amp; Emerging Technologies: <ul><li>Apply modern data and AI architecture patterns (Cloud Native, Steaming/batch ingestion, Agentic AI Design) and leverage platforms such as AI/ML, Big Data, and Data Lakehouse.</li></ul> Requirements: <ul><li>Minimum 8 years’ experience client facing roles specializing in Data and Architecture roles.</li><li>Experience in both Agile and Waterfall project environments.</li><li>Strong stakeholder management and communication skills.</li><li>Security and compliance awareness.</li><li>Industry certifications (e.g., AWS Solution Architect, Azure Data Engineer, GCP Data Engineer).</li><li>Experience mentoring or managing technical teams.</li></ul>

Responsibilities: <ul><li>To coordinate and facilitate meetings, ensuring accurate documentation through comprehensive minute-taking and timely distribution.&nbsp;</li><li>Manage visa application requests, end-to-end accommodation, travel arrangements, and logistical support for staff and visitors, ensuring efficiency, cost-effectiveness, and a seamless experience.</li><li>Responsible and liaise with 3rd party service providers to ensure timely and compliant processing of Professional Visit Pass (PVP) application for both staff and external vendors.</li><li>Manage with 3rd party service providers to ensure accommodation arrangements for long-stay foreign staff and vendors, including housing setup (apartment, condominium, or staff house), utility provisioning, and food delivery coordination.&nbsp;</li><li>Participate in internal and external audits, ensure timely closure of audit findings with proper documentation and evidence.</li><li>Ensure adherence to company policies and regulatory requirements, maintaining compliance across all administrative and operational activities.</li><li>Coordinating with the canteen service provider to ensure consistent food quality, hygiene and food quantity to meet the daily operation’s needs and to audit canteen timely manner and attend external audit if needed.</li><li>Manage telephone system and deal with service provider if having issue.</li><li>To manage office furniture. To deal with vendor and raise purchase requisition for new added or replacement.</li><li>Actively engage in safety, quality and compliance programs while providing comprehensive administrative support to operations.&nbsp;</li><li>Serve as the primary contact for internal departments and external suppliers in managing administrative matters with efficiency and professionalism.</li><li>Verify and review service provider / vendor billings to ensure accuracy, compliance with contractual terms, and timely processing.</li></ul> Requirements: <ul><li>Degree in business administration or related field.</li><li>Several years of experience working in an administrative role.</li><li>Effective communication skills in multiple languages, both written and verbal to engage with different level of employees and service providers across diverse regions.</li><li>Basic knowledge of office management systems and procedures.</li><li>Proficiency in MS Office (Word, Excel, PowerPoint).</li><li>Ability to handle sensitive information confidentially.</li></ul>

Responsibilities: <ul><li>Maintain contact with customers and ensure Company products are specified.</li><li>Achieve or exceed sales targets.</li><li>Identify design consultants and engineering contractors involved in projects with close and regular contact making us their preferred pump choice.</li><li>Identify upcoming projects and that the Pump Group specification is used.</li><li>Keep local and global team updated on projects by discussion and to maintain and progress projects.</li><li>Arrange and run customer training and presentations, which can be on-site and/or office based.</li><li>Feedback potential product improvements and complaints, where new applications offer greater potential but existing specifications exclude or lessen our suitability.</li><li>Increasing our market share by replacing other pump types as well as other manufacturers of peristaltic pumps.</li><li>Keep the Sales Manager updated with competitor activity encountered in the marketplace.</li><li>Identify, organize and progress field trials.</li><li>Identify and lead marketing activities maintaining our brand and finding new opportunities.</li><li>Keep CRM up to date with all customer activities.</li><li>Conduct all activities in accordance with the Quality Management System</li></ul> Requirements: <ul><li>Skilled negotiator to achieve sales targets.</li><li>Needs to work well with company co-workers, reps/distributors, and customers, and achieve desired results.</li><li>Ability to foster relationships with external institutes and organisations to promote interest in the use of our products</li></ul> Education and Experience Requirements: <ul><li>Minimum 5 years experience in mining sales.</li><li>Mechanical / Technical sales experience.</li><li>Experience in process engineering.</li><li>Advanced English writing/reading competencie</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>

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251 senior software engineer java + backend Jobs found

Site Quality Leader

Registered Operations Leader

Talent Acquisition Specialist

Data & ML Architect

Admin Support (Executive Assistant)

Sales Engineer, Mining

Sales Engineer, Mining

Sales Engineer, Mining

Sales Engineer, Mining

Associate Director RA & QA

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251 senior software engineer java + backend Jobs found

Site Quality Leader

Registered Operations Leader

Talent Acquisition Specialist

Data & ML Architect

Admin Support (Executive Assistant)

Sales Engineer, Mining

Sales Engineer, Mining

Sales Engineer, Mining

Sales Engineer, Mining

Associate Director RA & QA

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

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