Quality Manager

The aim of this position is to ensure that We are providing our customers with the highest level of parts and services while complying with regulatory requirements and applicable ISO standards. This is to be accomplished through quality and customer service expertise in managing the quality system and personnel at specified business unit(s) operations. This includes providing guidance for ISO 13485 and 21 CFR 820, using problem solving and quality tools appropriately, and interfacing with customers and 3ro party auditors all to ensure customer requirements are understood and met and the Quality Management System is effective. This position requires an in­ depth knowledge of quality management, quality engineering and customer service skills. Work is performed with a high degree of independence.

Essential Duties & Responsibilities --------------------------

1. 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.

1. Investigate, understand and convey customer expectations through continual customer interface via customer visits, meetings and conferences.
2. Manage internal audits of business unit operations systems in accordance with internal, regulatory, or customer driven requirements.
3. Identify, recommend and perform quality training as needed.
4. Communicate, identify and facilitate investigations into complaint issues. Approve and communicate results of investigation to customer representatives and authorize return of goods if necessary.
5. Manage maintenance and control of quality measurement instrumentation, production documentation and records.
6. Responsible for developing annual Quality Objectives with site leadership.
7. Manage the Latrobe site Master Validation Plan (MVP).
8. Identify needs for process controls and statistical analysis to ensure processes are stable and capable ongoing.
9. Chair the Material Review Board, Trend Analysis, and CAPA board meetings for Latrobe site.
10. Facilitate site-oriented customer and 3rd party audits.
11. Ensure segregation, containment, and disposition of nonconforming product in a timely manner.
12. Manage and monitor performance of suppliers and their products supplied to company
13. Ensure investigation and corrective actions are complete, implemented, and effective for product nonconformances, deviations, audit findings, and complaints.

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1. Reque st, interpret, and evaluate customer specifications.
2. Manage the preparation and submission customer requests for data, cont roll ed customer documents or any other requests.
3. 
   Act as the Quality System Management Representative for company .

Competencies

• Communication Skills
• Action Oriented
• Punctual/Reliable
• Att ention to Detail

#m1

ref: #282-Eng Pgh