APQP -Project Manager-Medical Devices

Bimbo Bakeries USA, Inc.; Oberursel (Taunus); Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading company in the hospitality sector seeks an experienced professional for quality assurance role focusing on supplier management and compliance. This position requires extensive knowledge of manufacturing processes, particularly in validation techniques, along with strong technical writing abilities. Effective communication skills in both German and English are essential as the role involves liaising with suppliers to maintain high quality standards.

Qualifikationen

• 12+ years in manufacturing quality support.
• Experience with APQP and ISO 9001, 13485 preferred.
• Effective communication in German and English.

Aufgaben

• Partner with manufacturing sites to ensure quality compliance.
• Manage validations of special processes and technical documentation.
• Drive quality improvements with suppliers.

Kenntnisse

Technical Drawing

Manufacturing Process

Quality Assurance

Lean Improvements

Effective Communication

Jobbeschreibung

Job Description

• Partner with Manufacturing Sites, Operations and Procurement personnel to proactively engineer quality and ensure compliance for raw materials, components, finished products etc., from suppliers.

• The job requires working with R&D and procurement to implement advanced product quality planning(APQP) including special process validation PV (IQ/ OQ/ PQ/TMV) on purchased parts for FDA remediation tasks.

• The Job role requires associate to be familiar with special processes where validation is required, such as but not limited to welding, soldering, crimping, injection molding, plating, casting, and thermal forming and be capable of writing technical documents in English.

• Review part to determine if special processes were used within the manufacturing of the part, confirm if proper validation was/needs completed.

• PV (process validation) Completion of PV protocol/ report with manufacturer and submitting IQ/OQ/PQ/TMV Protocols and Reports.

• APQP (Advanced Product Quality Plan) Completion of SRPQP, PSW Agreement, PSW Final report Submission.

• Develop and support regulatory compliance gaps at suppliers, including supplier quality system and process development activities.

• Manage additions/deletions/changes to the status of suppliers on the Approved Supplier List, including supplier master file records

• Ensure raw materials/components/products at supplier(s) are released from supplier(s) to Philips according to the agreed requirements.

• Perform 3rd party product compatibility risk assessments in partnership with R&D and Market Procurement (Markets SQE).

• Drive quality and compliance development and/or improvement at suppliers when needed; Philips face to supplier(s) on lean improvements.

Looking for candidates with 12+ years of experience with:

• Experience in leading a large team for Manufacturing quality support.

• Experience with technical drawings, specifications of parts.

• Experience in Manufacturing process of welding, soldering, crimping, injection molding, plating, casting, and thermal forming

• Experience with APQP (IQ,OQ,PQ) preferred.

• Technical writing of protocols and reports.

• Experience in ISO 9001, 13485 a plus.

• Effective communication skills in German( Deutsch) and English.

• Ability to travel to supplier sites within assigned region.

• Ability to speak and communicate with local suppliers in native language and in English.