By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

At Integer, our values are embedded in everything we do.

Customer

We focus on our customers' success

Innovation

We create better solutions

Collaboration

We create success together

Inclusion

We always interact with others respectfully

Candor

We are open and honest with one another

Integrity

We do the right things and do things right

Position scope/summary

• Quality Systems Engineer is responsible to support on the administration of the Quality Management System.
• Coordinate the Internal Audit Process
• Participate on customer audits including audit responses.
• Co-responsibility to ensure that all associated documentation and procedures associated with areas of responsibility comply including trending and reporting of these activities.

Essential duties and responsibilities

• Administration of Quality Management System for compliance with established standards, client and/or medical devices industry requirements, government regulations, and other applicable standards specifically ISO 13485, 21 CFR Part 820, COFPERIS, Japan and Brazil and or GMP regulatory requirements related to medical devices industry.
• Administration of Internal Audit process based on requirements of medical devices industry.
• Act as Lead Auditor or team member.
• Coordinate audits activities with team members including review of audit reports and provide technical assistance.
• Review audit results with coordinator and other assessment team members to verify and document evidence of compliance to ensure audit findings are solved.
• Coordinate audit meetings and follow up of audit findings.
• Provide management with updates on status of work, initiatives and projects as required.
• Liaison with client regarding audit activities
• Participate actively in customer audits.
• Support on KPI reports
• Administration and Control quality records according to retention period established (e.i storage and retrieval)
• Administration and control of customer and external documentation.
• Support and conduct CAPA process as required.
• Promote and maintain a culture and attitude of continuous improvement, working within the company team to make it more efficient, safety and an enjoyable place to work.
• Collaborate with process owners and department personnel to change, improve, and create process documentation such as forms and standard operating procedures based on Good Manufacturing and documentation Practices.

Qualifications

• Bachelor's degree (Engineering, Administration or equivalent)
• Microsoft Office experience (word, outlook, excel)
• Minimum 3 to 5 years' experience in GMP Audits in the medical device industry
• Medical Device Quality System Knowledge Including 21 CFR Part 820 (QSR) & ISO 13485
• Advanced English
• Strong communication skills (verbal, written and presentation)
• Must have good interpersonal and negotiation skills.
• Must have experience and working knowledge in the Quality discipline, Medical Device manufacturing.

U.S. Applicants: EOE/AA Disability/Veteran