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Form of workJob Description
Description
Key Responsibilities
Skills Knowledge and Expertise
The Sr. Design Quality Engineer shall provide support to new product development projects and ensure compliance in the support of medical devices during the device life cycle process. The Sr. Design Quality Engineer will serve as a subject matter expert on the requirements and processes for product lifecycle management. The Sr. Design Quality Engineer will also assist in such activities such as CAPA, auditing, design and process verification/validation activities and change control review.
Key Responsibilities
- Ensures that product development projects and changes to current products are conducted in compliance with the FDA Quality System Regulation Design Phases and within Exactech Quality Management System.
- Participates in cross-functional teams to review requirements to develop product requirements that support the marketing needs.
- Participates in cross-functional team to develop risk managements files (plans, assessments and reports)
- Review new and modified product design for manufacturability, inspectability and critical to quality characteristics.
- Develops Quality inspection plans.
- Assists on the purchases of inspection equipment and fixtures as required.
- Provide guidance and direction for testing methods and adequate sample size using statistically valid techniques to support verification and validation requirements.
- Provides design and process verification and validation expertise during protocol development and execution
- Develops and validates, using statistical methodologies and quality inspection sampling plans for internally manufactured and vendor supplied products, processes and components.
- Assist, when appropriate, with internal and supplier audits.
- Leads and/or participates in company-wide Corrective and Preventive Actions projects.
- Provide Quality support to facilitate resolution of product nonconformities.
- Assists in product/process analysis and investigations related to customer complaints.
- Direct or assist training of QC inspectors and QE technicians on inspection methodologies.
- Provides leadership role on championing departmental or cross-functional engineering initiatives.
- Act as an effective leader/team member in supporting quality disciplines, decisions and practices.
- Provide sound problem-solving methodologies in identifying, prioritizing, communication and resolving quality issues.
- May act as independent reviewer for technical documentation.
- Know and apply the Quality System and any appropriate Federal and International standards.
- Assist and support other team members as necessary.
Skills Knowledge and Expertise
Education:
- Bachelor’s Degree from an accredited institution required; Master’s Degree preferred
Experience:
- Minimum 7 years’ experience in the medical device industry
- Experience in GD&T and use of advanced inspection equipment
- ASQ CQE and CQA certification desirable
- 21CFR820, ISO13485, ISO14971, CMDR and MDR
Functional/Technical Knowledge, Skills and Abilities Required:
- Understanding and application of statistical analysis and sampling plans
- Understanding and application of Design Control and Risk Management
- Ability to work effectively in a team environment
- Advanced level of technical software proficiency
- Advanced Quality Systems knowledge required
