Supplier Quality Engineer
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Job Location:
Indianola, WA - USA
Monthly Salary:
Not Disclosed
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor; Michigan that offers strategic talent solutions to our clients worldwide. This client is a German multinational Pharmaceutical and biotechnology company and one of the largest pharmaceutical companies in the world headquartered in Leverkusen and areas of business include pharmaceuticals; consumer healthcare products agricultural chemicals seeds and biotechnology products.
Job Title: Supplier Quality Engineer
Location: Indianola PA 15051
Duration: 11 Months
Job Type: Temporary Assignment
Work Type:Onsite
Job Description:
DEPARTMENT/TEAM DESCRIPTION:
- The Pharma-Radiology Supplier Quality Team is responsible for the quality of supplied materials and services that are used in the manufacturing of medical devices.
- This includes interactions with various parts of the organization from New Product Development through Life Cycle Engineering.
POSITION DUTIES & RESPONSIBILITIES:
- Lead supplier qualification activities for new components and processes to support production launch readiness of a new medical device.
- Plan execute and document component and process qualification activities
- Review and interpret supplier documentation to support qualifications such as FAIs pFMEAs Control Plans Process Flow Diagrams IQ/OQ/PQs.
- Ensure supplier process capability meets design and quality requirements through capability studies (Cpk) and statistical analysis.
- Collaborate with R&D Mechanical and Electrical Design Engineers and other internal stakeholders to ensure supplier capabilities and manufactured parts align with design intent and resolve discrepancies.
- Serve as the quality interface between the R&D organization and selected suppliers.
REQUIRED QUALIFICATIONS:
- Bachelors degree in engineering or other related technical discipline required
- 4-7 of experience in a quality-related role within a regulated industry (medical device preferred).
- Strong working knowledge of qualification and validation methodologies including IQ/OQ/PQs pFMEAs Control Planes Capability studies (Cpk) Gage R&R and measurement system analysis First Article Inspections.
- Ability to interpret engineering drawings specifications and technical requirements.
- Strong written and verbal communication skills including supplier-facing interactions.
PREFERRED QUALIFICATIONS:
- Knowledge of manufacturing processes such as injection molding PCB manufacturing and assembly machining and casting
- Familiarity with ISO 13485 and ISO 9001
KEY COMPETENCIES:
- Risk-based decision making
- Technical problem solving
- Supplier relationship management
- Cross-functional collaboration
- Attention to detail and documentation rigor
- Ability to operate independently in a project-driven environment
TekWisen Group is an equal opportunity employer supporting workforce diversity.
Key Skills
- Project / Program Management
- Change Management
- Succession Planning
- Procurement
- Program Management
- ISO 9001
- Lean Six Sigma
- Quality Systems
- Quality Management
- Supplier Management
- HACCP
- As9100
