Senior Design Quality Engineer

Sectors:
Aerospace, shipbuilding, other transport equipment, Automotive, Electrical, optical, Engineering
Locations:
International
Qualifications:
Not specified
Contract type:
Permanent
Hours:
Full time
Salary description:
Competitive
Sub-sectors:
All
Specialist areas:
Quality assurance (main), Audit/assessment, Consultancy, Health and safety, Operational improvement, Project management, Risk management
Posted:
17/09/2020
Start Date:
ASAP
Recruiter:
Exactech, Inc.
Job Ref:
950236315

1. 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.
2. Participates in cross-functional teams to review requirements to develop product requirements that support the marketing needs.
3. Participates in cross-functional team to develop risk managements files (plans, assessments and reports)
4. Review new and modified product design for manufacturability, inspectability and critical to quality characteristics.
5. Develops Quality inspection plans.
6. Assists on the purchases of inspection equipment and fixtures as required.
7. Provide guidance and direction for testing methods and adequate sample size using statistically valid techniques to support verification and validation requirements.
8. Provides design and process verification and validation expertise during protocol development and execution
9. Develops and validates, using statistical methodologies and quality inspection sampling plans for internally manufactured and vendor supplied products, processes and components.
10. Assist, when appropriate, with internal and supplier audits.
11. Leads and/or participates in company-wide Corrective and Preventive Actions projects.
12. Provide Quality support to facilitate resolution of product nonconformities.
13. Assists in product/process analysis and investigations related to customer complaints.
14. Direct or assist training of QC inspectors and QE technicians on inspection methodologies.
15. Provides leadership role on championing departmental or cross-functional engineering initiatives.
16. Act as an effective leader/team member in supporting quality disciplines, decisions and practices.
17. Provide sound problem-solving methodologies in identifying, prioritizing, communication and resolving quality issues.
18. May act as independent reviewer for technical documentation.
19. Know and apply the Quality System and any appropriate Federal and International standards.
20. Assist and support other team members as necessary.

Job Requirements:

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

Closing Date:
15/10/2020
Contact Details:
Exactech, Inc.
Contact: Click apply

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