Sr. Design Assurance/Quality Engineer
Contraline is seeking a Sr. Design Assurance/Quality Engineer to actively manage Design Controls and Risk Management activities for our medical devices. This position requires maintaining up-to-date knowledge of all applicable international and regulatory guidance and GMP standards, as well as in-depth product knowledge.
The successful candidate will need strong leadership, problem-solving, and high moral standards to excel in this role while also being flexible (wearing multiple hats) and able to work in a small, dynamic, and innovative environment. This role reports to the VP of Quality and Operations.
- Partner with R&D to drive design assurance activities on product development projects, planning, design requirements & specifications, and technical standards.
- Lead Risk management activities in conjunction with our R&D team
- Lead Design Reviews and manage related records and activities to completion
- Lead Design Transfer activities with R&D and Operations
- Provide feedback on design documentation, planning, user needs, inputs, specifications, verification and validation activities
- Collaborate cross-functionally to plan, execute, and document design controls, risk management, and method/equipment verification/validation, as applicable
- Oversee change management for design changes
- Partner with design teams on human factor study development and execution
- Collaborate with internal and external partners on component qualification
- Maintain Design History and Risk Management Files along with related records for Contraline products (DHF/RMF, DMR, DHR, etc.)
- Provide Quality Engineer and Design Assurance support to Engineering and Operations to ensure risk-based approaches and compliance with applicable regulations
- Drive and support updates to Quality System documentation as needed
- Assist in supplier sourcing and performance management activities
- Support internal, external and supplier audits as needed
- Manage supplier communication and assess for appropriate change management activities
Experience and Qualifications
- Strong experience operating within the requirements of FDA 21CFR820 and ISO13485
- Thorough understanding and application of ISO14971 and related subparts throughout the product lifecycle
- Proficiency in process analysis and optimization.
- Familiarity with product development best practices including design transfer
- Proficiency with supplier sourcing and ongoing management
- Experienced with statistical significance and its broad application to design, testing, and manufacturing
- Strong interpersonal skills, communication (verbal and written), organizational and project management skills
- Ability to motivate and influence people to ensure enterprise-wide compliance to regulatory requirements
- Committed to a team-oriented approach
- Ability to work both independently and with general direction
- Ability to travel, when requested
Education & Experience:
- Bachelor’s degree or equivalent experience (engineering or technical discipline degree desirable)
- 5+ years experience in a quality role (quality engineer, design assurance, reliability engineer) in medical device
- Previous experience in design controls/risk management and related records, specification writing, statistical analysis, report writing, design transfer and medical device design reviews.
- Demonstrated experience and responsibility for compliance for FDA, MDD and ISO regulations
- ASQ Certification preferred
- Experience with Greenlight Guru is a plus
Upload your resume to apply for this role through CvilleBioHub. If the company accepts applications through email, they will also receive your resume.