Flex Senior Quality Engineering 

United States, New Hampshire 

45002228

Farm, a Flex company with over 50 years of experience in providing award-winning development services for medical, life sciences, and consumer healthcare sectors, is seeking a

based in

Hollis, New Hampshire

.

The

Here is a glimpse of what you’ll do:

• Support product development as an embedded program team member working alongside program managers, researchers, human factors engineers, designers, mechanical engineers, and electrical engineers
• Provide guidance to program teams on compliance with the quality management system
• Assist program managers with development, review, approval, and updates to program documents
• Assist program managers with development, review, and updates to program and quality planning documents
• Collect and manage content of program design history files (DHF)
• Review applicability of customer product requirements and risk management documentation to programs and deliverables
• Coordinate milestone and technical reviews with program teams
• Collaborate with program teams for planning and documentation for prototype builds including, but not limited to control of the design; development of build plans; acceptance of materials and documentation of assembly processes
• Lead planning and documentation for prototype testing including, but not limited to creation of test plans; development of test methods; coordination of data collection, analysis & audit, and completion of test reports
• Manage quality management system processes including, but not limited to training records, calibration records, supplier records, engineering change orders (ECO) and documentation control
• Establish, evaluate, qualify, encourage use of and continuous improvement to processes, procedures and standard tools used by program teams
• Participate in internal, customer and notified body audits of the quality management system
• Lead corrective action and preventive action resolution
• Interacts with customers, suppliers, and external auditors to develop close working relationships.
• Participates in customer strategy meetings and discussions regarding the development of program quality requirements and plans.
• Participates in the design review process on development programs.

The experience we’re looking to add to our team:

• Bachelor's degree in Engineering or related field or equivalent experience and training.
• 4+ years of quality experience .
• 2+ years of medical devices experience
• ISO13485/ FDA/ 21cfr 820.30
• Previous product development / design control experience
• ISO 13485 Internal or Lead Auditor Training (Preferred)

What you'll receive for the great work you provide:

• Full range of medical, dental, and vision plans
• Life Insurance
• Short-term and Long-term Disability
• Matching 401(k) Contributions
• Vacation and Paid Sick Time
• Tuition Reimbursement

Design, Process & Technology Engineering