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Quality Assurance Manager - ISO13485
ISO 13485 and Electrical Background required
Engineering Degree for high level quality leadership role
About Our Client
Michael Page is partnering with an OEM Medical device company west of Boston. Though already well established with sites around the world, they have strong growth projections over the next few years. This company manufactures and sells multiple product lines that typically have an electronic or surgical application, and are continuing to bring new products out to market every year.
The Quality Assurance Manager ISO13485 will:
- Develop and maintain Quality Management System in accordance with domestic and international medical device regulatory requirements (FDA, ISO13485, etc)
- Establish and lead Quality team with the skills and abilities necessary to support the Quality Management System and the goals of the organization.
- Oversee the Quality Management System including complaint handling, corrective and preventive actions, internal audit program, supplier quality assurance, product inspection and release, equipment calibration and control of nonconforming material.
- Lead Quality Engineers in the implementation of an effective product development process that complies with design control requirements.
- Establishes quality metrics monitoring, trending, response, and promotion to corrective actions as appropriate.
- Identify process improvement opportunities. Implement and develop processes and procedures that create the greatest value for the organization.
- Promote a culture of quality and continuous improvement throughout the organization.
- Partner effectively with Engineering and Manufacturing to ensure quality standards are being met.
- Ensure site readiness for external audits.
- Participate in inspections by regulatory agencies.
The Successful Applicant
The Quality Assurance Manager - ISO13485 will have:
- Bachelor's degree in Engineering, preferable Electrical Engineering
- Minimum of 5 years of professional experience and understanding of product development, manufacturing, quality control and servicing in a medical device or pharmaceutical industry.
- Minimum 3 years supervisory/ management experience, including hiring, training, coaching and performance management activities, five or more years of management/leadership and development experience preferred.
- Working knowledge of FDA QSR, ISO, MDD, CMDCAS and/or other international quality systems requirements
What's on Offer
- Well established and growing company
- OEM Medical device with multiple product lines
- Great team culture
- Work/Life Balance
- Competitive compensation package