Quality Engineer
Posted on :
08-11-2022
Employer Active
1 Vacancy
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Job Description
Responsibilities:
Requirements:
4+ years' experience working in the Medical Device or Medical Device Combination product industry
- Represent the Quality function on product and process development project teams.
- Actively support and engage in design reviews.
- Lead or support design activities including design verification, validation, specification setting and justification, test method development, usability
- engineering, and risk management.
- Evaluate protocols and reports to ensure that the testing is sufficient to meet regulatory requirements (e.g. ISO 10993, 13485, 22442, 62366) and quality
- objectives.
- Generate or apply statistical methods with appropriate risk-based justification.
- Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and
- verified.
- Promote continuous improvement in design control activities and use of quality tools with design team.
- Define critical to quality characteristics and inspection plans for components, subassemblies, and finished devices.
- Identify and propose remediation for existing and potential quality issues; act as project team quality solution provider to maintain compliance Quality System
- Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation, ISO 13485 Regulations, and other applicable standards.
- Maintain expertise in both current and emerging requirements and quality trends as they relate to medical device and combination products worldwide.
- Provide Risk Management support to quality subsystems of Health Hazard Evaluation/Health Risk Assessment process, Risk Management Review, Quality System Management Review, and Post Market Surveillance.
- Act as Risk Management subject matter expert (SME); provide guidance on impact to existing risk assessments due to change control and quality system improvements.
Requirements:
- Experience in Medical Device design and development activities; core team member role preferred
- Experience leading product risk analysis and management throughout development lifecycle
- Experience with injection molding and assembly preferred
- Experience with animal and human tissues (HCT/Ps) regulation is a plus
- Familiar with reliability analysis and test methods and test method validation
- Familiar with process validation principles, including sub-tasks of equipment IQ, OQ, PQ
- Strong verbal (including presentation) and written communication skills, especially technical report writing
- Working knowledge of 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, ICH Q9 Guidance for Industry Quality Risk Management, 21 CFR 4 Regulation of Combination Products, SOR 98 282 Canadian Medical Device Regulation, ISO 14971 Risk Management Standard, MDD, MDR, ISO 22442 Animal Tissues, IEC/EN 62366 Application of Usability Engineering to Medical Devices, and ANSI HE75 Human Factors Engineering in Design of Medical Devices
- Ability to effectively influence others without direct authority and partner with internal and external customers
- Experience interacting with regulatory agencies and notified bodies; front room audit experience is a plus
- Knowledge and experience with corrective action and preventive action system, release test statistical sampling methods, quality risk management, FMEA, DOE and other key tools for managing quality performance
- CQE preferred
4+ years' experience working in the Medical Device or Medical Device Combination product industry
Employment Type
Full Time
Key Skills
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