Quality Engineer (Medical Devices)

Job#: 1358290

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Quality Engineer (Medical Devices)

Apex Systems is a large staffing and consulting firm and we are looking for a Quality Engineer with experience in CAPAs, cGMP documentation regulations such as ISO 13485 and/or ISO 14971, establishing acceptance criteria, experience with QMS systems and complaint handling for one of our biotech clients in Toronto.

Client: Biotechnology company

Contract/Perm & duration: 6-9 month contract

Location: Toronto

This position will be working 3-4 days onsite a week.

As a Quality Engineer within the Medical Device Quality Assurance, you will work with product development teams focusing on medical devices and medical device combination products. You will utilize knowledge and skills to provide guidance to operational teams and project teams related to design controls (21 CFR 820), risk management (ISO 14971), risk assessments, Corrective and Preventative Action (CAPA) and other applicable regulatory requirements for the medical device or the device constituent of combination products. You will work with the development teams and other organizations to advance new concepts and methodologies. The Quality Engineer will be an advocate for quality, who collaborates with other functional teams reviewing design control deliverables to ensure the developed products are safe and effective.

Responsibilities:

• Lead and facilitate Risk Analysis, Control and Mitigation per ISO 14971. Review and approve risk management file documents.
• Work closely with Contract Manufacturing Organizations (CMO) to set up the manufacturing process, review and approve process design documents such as process characterization, process validation, and participate in manufacturing reviews.
• May author R&D/Quality procedures for maintenance/creation of design history files and other supporting documentation.
• Contribute to establishing, maintaining and revising internal procedures. Maintain knowledge of current industry standards and trends in best practices.
• Work with Device Development to establish and/or review acceptance criteria, test methods, protocols, instructions and related validations to assure product quality.
• Other quality duties as assigned (e.g., document control, quality event review, training, batch record review and disposition, etc.)
• May perform supplier audits and qualify new suppliers.
• Review and approval of quality issues (e.g. deviation, investigations) and technical matters (e.g. design changes, verification and validation protocols and reports) with impact to design control and risk management. As required, lead investigations, root cause analyses and CAPAs.
• Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercise judgment within generally industry defined practices and policies in selecting method and techniques for obtaining solutions.
• Ensure device design/development and device/drug product development meets appropriate regulatory requirements by providing pro-active guidance through all stages of development in accordance with applicable medical device regulations, technical standards, and internal company QMS requirements.
• Participate in Medical Device/Combination Product Development projects as assigned. Review and approve R&D/Quality documentation (e.g. Design Inputs, Design Outputs, Design Verification/Validation, Risk Management File, Design Verification/Validation)
• Act as the medical device quality engineer resource to support new product development.

Key Qualifications:

• Experience in change management of either medical devices or medical device combination products.
• Bachelor’s Degree or equivalent in a scientific/engineering discipline (chemical, mechanical or biomedical engineering)
• Knowledge in area of statistics of quality including sample size analysis, power calculations, confidence and reliability, capability analysis, etc.
• Atleast 2 years’ experience of working in a Quality Assurance role for medical device/combination product.
• Technical knowledge related to the design/operation of medical device or drug combination product platforms, design controls, risk management, 21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR.
• Experience in the design and development of medical devices or combination products.
• Knowledge and application of device root cause analysis methodology and device CAPA requirements.

Preferred Qualifications:

• The combination of strong pharmaceutical and medical device development experience preferred. Master’s degree preferred.
• ASQ CQE Certification.
• Extensive experience in risk management and design control of medical devices or combination products from concept through launch.
• Knowledge in statistical analysis including strong knowledge of statistics of quality and experience with least one statistical analysis software system.
• Experience working with contract manufacturing organizations (CMOs) and contract testing labs including auditing, negotiation of Quality Agreements, and resolving quality issues.
• Proven ability to identify quality issues and effectively and proactively investigate and efficiently resolve issues in a team setting.
• Understanding and application of cGMP specifically 21 CFR 820, Rule 21 CFR “4” current good manufacturing requirements for Combination Products and the principles and concepts of relevant quality processes and systems.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

4400 Cox Road

Suite 200

Glen Allen, Virginia 23060

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] (Do not submit resumes or solicit consultants to this email address). UnitedHealthcare creates and publishes the Transparency in Coverage Machine-Readable Files on behalf of Apex Systems.