Site Quality Leader

Registered Operations Leader

Talent Acquisition Specialist

Data & ML Architect

TA Supervisor

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: Execute Hiring Strategies; <ul><li>Collaborate with Regional TA Manager, Business Leaders, HR partners, and Business teams to understand short- and long-term hiring needs.</li><li>Assist in developing and executing hiring plans, executing Global SLAs are aligned with the Business Goals</li><li>Stay informed about industry trends, market conditions, and emerging hiring practices &amp; tool</li></ul> Talent Sourcing &amp; Pipeline Development: <ul><li>Build and maintain a strong pipeline of candidates for various key roles such as NPD, NPI, PDE, MPDE and many more.</li><li>Assist the Regional TA Manager to develop and implement innovative hiring strategies using Market intelligence &amp; Talent Mapping tools.</li><li>Leverage a mix of sourcing channels: Internal/External career sites, social media Hiring such as LinkedIn, TikTok, Instagram, Facebook etc., Job Boards such as JobStreet, Monster</li><li>Familiar with hiring tools such as HireEz, ZoomInfo. Leverage employee referrals, and University hiring</li></ul> Employer Branding &amp; Candidate Engagement: <ul><li>Position the company as an employer of choice in the Engineering, Tech and manufacturing space.</li><li>Create content and campaigns targeting industry professional (e.g., webinars, blog posts, meetups, TechEvents)</li><li>Craft compelling job descriptions and recruitment materials tailored for manufacturing, Production and Engineering professionals</li></ul> Full-Cycle Recruitment: <ul><li>Deliver end-to-end recruitment: sourcing, screening, interviewing, offers &amp; compensation negotiation and onboarding</li><li>Collaborate with hiring managers to define role requirements and ideal candidate profiles.</li><li>Assist implement and monitor structured interview processes, including technical assessments</li></ul> Stakeholder Management: <ul><li>Act as the primary liaison between candidates and internal stakeholders</li><li>Provide regular hiring updates, metrics, and insights to leadership</li></ul> Data-Driven Recruiting: <ul><li>Use analytics to track sourcing effectiveness, time-to-hire, offer acceptance rates, and pipeline health.</li><li>Ensure Global Hiring Metrics, SLA and targets are aligned and achieved</li><li>Publish Daily / Weekly / Monthly / Qtrly reports on the efforts and progress</li><li>Optimize hiring funnel using recruitment metrics and KPI</li></ul> Requirements: <ul><li>Overall 8+ years of experience with Minimum of 5+ years from relevant industry</li><li>Preferably an Engineer of any discipline, but not mandatory (OR) Bachelor’s degree or higher in business administration or related field</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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208 senior emc engineer Jobs found

Site Quality Leader

Registered Operations Leader

Talent Acquisition Specialist

Data & ML Architect

TA Supervisor

Sales Engineer, Mining

Sales Engineer, Mining

Sales Engineer, Mining

Sales Engineer, Mining

Associate Director RA & QA

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Skills

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208 senior emc engineer Jobs found

Site Quality Leader

Registered Operations Leader

Talent Acquisition Specialist

Data & ML Architect

TA Supervisor

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