Quality Engineer (Medical Device)
Posting ID: JP-001976741
• Quality assurance support in the design and development support of medical device products, facilitating the application of design/change controls, risk management, quality plan, and implementation of design and development plan.
• Act as SME for key subsystems such as Design Control, Risk Management, Design Verification, Design Validation, Process Validation, etc.
• Provides QA support for internal Quality Systems growth.
• Implements and maintains quality systems, policies, and procedures that ensure compliance with ISO 13485, cGMP, FDA (i.e., 21 CFR part 11, 21 CFR part 803, 21 CFR part 806, 21 CFR part 820, 21 CFR 822) and other applicable standards.
• Quality oversight of internal and external process characterization project plans, protocols, and reports.
• Activities to include authoring, issuance, and review of regulated documents and ensure processes and products comply with current Good Manufacturing Practices and 21 CFR 820.
• Review and approve project documents to ensure adequate coverage for the project's defined scope.
• Knowledge of cGMP, FDA/EMA regulations.
• Support regulatory inspections by FDA and foreign regulatory agencies.
Additional Skills & Qualifications:
- BS in Engineering (or equivalent) and a minimum of 4 years' experience in the regulated medical device industry as a Quality Assurance Engineer supporting new product development is preferred.
- Excellent Quality System knowledge required. Practical experience with ISO 13485, FDA Quality System Regulations, Good Manufacturing Practices, Good Documentation Practices, ISO 14971, and other applicable standards.
- Working knowledge of principles, concepts, and practices for design and development activities, Risk Management, FDA 510K submissions, and ISO Regulations.
- MasterControl experience strongly preferred.
- At least 3-4 years quality engineering experience in medical device.
- Bachelors degree in Engineering preferred but not required with appropriate experience
- Knowledge and familiarity with product development quality (i.e. design control, risk management, design verification/validation, and process validation)
- Practical experience with ISO 13485, FDA Quality System Regulations, Good Manufacturing Practices, Good Documentation Practices, ISO 14971, and other applicable standards. (this should come from being in medical device)
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Legath, Benjamin