Our client needs a Quality Manager . The ideal candidate will have 5 years’ experience as a Quality Manager or in a Senior Quality Engineering role in an FDA regulated facility. Other areas of interest would be six sigma, medical device, auditing and SPC.
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- Ensure plant compliance to 21 CFR 820 and ISO 13485 and conformance with established processes and customer requirements and expectations through management of the quality system and personnel.
- Investigate, understand and convey customer expectations through continual customer interface via customer visits, meetings and conferences.
- Manage internal audits of business unit operations systems in accordance with internal, regulatory, or customer driven requirements.
- Identify, recommend and perform quality training as needed.
- Communicate, identify and facilitate investigations into complaint issues. Approve and communicate results of investigation to customer representatives and authorize return of goods if necessary.
- Manage maintenance and control of quality measurement instrumentation, production documentation and records.
- Responsible for developing annual Quality Objectives with site leadership.
- Manage the Master Validation Plan (MVP).
- Identify needs for process controls and statistical analysis to ensure processes are stable and capable ongoing.
- Chair the Material Review Board, Trend Analysis, and CAPA board meetings for site.
- Facilitate site-oriented customer and 3rd party audits.
- Ensure segregation, containment, and disposition of nonconforming product in a timely manner.
- Manage and monitor performance of suppliers and their products supplied to our site.
- Ensure investigation and corrective actions are complete, implemented, and effective for product nonconformances, deviations, audit findings, and complaints.
- Request, interpret, and evaluate customer specifications.
- Manage the preparation and submission customer requests for data, controlled customer documents or any other requests.