Senior Quality Engineer - Design Assurance
About the role
The Senior Engineer, Quality Assurance for Mammotome is responsible for supporting Design Control and Risk Management activities to bring new products to market, ensuring product compliance to applicable standards and regulations, and collaborating with cross-functional teams to maintain adherence to Mammotome’s Quality Management System.
Responsibilities
- Supports Design Control and Risk Management activities for new product development (NPD) and sustaining projects.
- Maintains project risk management files, including risk plans, hazard/failure mode effects analysis, risk mitigations, and effectiveness checks.
- Authors updates to applicable corporate quality procedures in response to new standards, regulatory requirements, or process improvement initiatives.
- Provides independent technical support of design control and risk management to address systemic quality issues and support internal and external audits.
- Assists in training company employees on the principles of Quality and other QMS elements.
Requirements
- Bachelor’s degree in engineering from an accredited college or university.
- Minimum of 5 years of experience in an engineering role in the medical device industry.
- Comprehensive knowledge and experience of international medical device quality systems regulations and standards, including but not limited to 21 CFR 820, ISO 13485, and ISO 14971.
- Strong knowledge and experience in the application of design control principles to medical device design and development.
- Knowledge and experience with process validation and manufacturing qualifications.
Qualifications
- Ability to travel – Must be able to travel up to 10% of the time. Overnight travel will be required.
- Valid driver’s license with an acceptable driving record.
- Ability to lift, move or carry equipment up to 10lbs.
SkillsLeading audits with external auditors and/or Notified Bodies
Benefits
At Mammotome, we offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance, and a 401(k) to eligible employees. The annual salary range for this role is $100,000 to $120,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay.