Lead a small team of Technicians and Inspectors in supplier quality, audits, inspections, writing SOPs, reporting data to customers, corrective actions, coordinating external auditor visits and generally supporting Production.
In this role, In this role, the selected candidate must have plans, controls and assures product and process quality and application in accordance to with quality principles (design and manufacturing.)
In this role, the selected candidate will work closely with the Quality Manager in managing the quality planning efforts to ensure the product and processes are being developed and continuously reviewed as to their effectiveness in meeting established standards.
The Quality Engineer provides leadership and guidance to the organization acting as a change agent to implement process improvement across the organization in the achievement of an operational excellence environment.
Ability to use strong industry knowledge to relate to customer needs and dissolve customer concerns and high level of focus and attention to detail.
Strong work ethic with good time management with ability to work with diverse teams and lead meetings
Monitoring of inspection and functional test data, and isolates potential problem areas as indicated by significant lot-to-lot data shifts. Participation in compliance and process audits, both internal and external.
This position will be responsible for assisting reviewing and approving APQP documents, reviewing MSA studies for accuracy, reviewing risk assements and their affect on processes, and ensuring sampling processes are statistically based.
The Quality Engineer will lead and facilitate the implementation of site specific quality initiatives and their continual improvement. Responsible for the site quality engineering activities of leading, coaching, and facilitating problem solving, analysis of data and continual improvement activities.
Coordinate the updating and contemporization of the design history file documentation of a variety of products (Type 1 and 3 devices, convenience kits, and combination products) with the support of a multi-disciplinary team to meet current ISO 13485 and EU MDD regulatory requirements.
The Quality Engineer will lead a small team of Technicians and Inspectors in supplier quality, audits, inspections, writing SOPs, reporting data to customers, corrective actions, coordinating external auditor visits and generally supporting Production.
Responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Interacts with many different functional departments, suppliers, and experts outside Zimmer to implement Zimmer Quality goals.