The Senior Design Quality Assurance Engineer supports the Product Development and Sustaining Engineering teams and plays a key role in the Design Control process. This role will apply knowledge of Design Control principles and quality engineering techniques to positively influence new product development efforts, including those for design verification, validation, specification development, and risk management.
The Senior Design Quality Assurance Engineer is also the developer of the essential requirements checklist, technical file summary, and design history file documents that demonstrate product complies with applicable regulatory requirements.
Duties and Responsibilities
- Create design verification and design validation protocols, plans, and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
- Performs research, design and development of test methods used in design verification and design validation.
- Identification and review of applicable product standards used in design verification and design validation.
- Provides input to design and manufacturing drawings, inspection procedures, and manufacturing procedures to ensure that the resulting products can be adequately manufactured and tested.
- Supports development and reviewing of all design history deliverables for hardware, software, and the integrated system to satisfy essential requirements checklist and technical file compliance requirements.
- Data review and analysis from key testing activities.
- Participating in Design Stage Reviews and process validation activities related to Design Transfer to Manufacturing.
- Participation in product qualification testing and system certification, i.e. EMC, RoHS, CE
- Knowledge of Measuring and Test Equipment
- Participation in audits for areas of expertise
- Support process validations (IQ, OQ, PQ)
- Performs various risk management activities such as risk analysis, FMEA, FTA.
- Support CAPA investigations related to Design Assurance opportunities
- Provide input to QMS enhancements as identified
Required Knowledge, Skills, and Abilities:
- Strong working knowledge of CFR 820.30 Design Controls along with other FDA Quality System Regulations, ISO 13485, Medical Device Directive, and Active Implantable Medical Device Directive and supporting standards/regulations.
- Able to work within a quality system at a medical device development and manufacturing facility
- Able to construct statistically valid test plans and contribute to verification and validation activities
- Able to design and implement statistical methods and design of experiments to support process control and product improvement
- Good communication and interpersonal skills
- Good writing skills
- Organized and detail oriented
Required Credentials and Experience:
Minimum of 7-10 years of experience in quality/design engineering positions at medical device companies
Bachelor’s degree in an engineering discipline
ASQ certifications desirable
Job Type: Full-time
- Design Quality Assurance Engineering: 7 years (Preferred)