Validation Quality Engineer at Katalyst Healthcares Life Sciences
Waukesha, Wisconsin, USA -
Full Time


Start Date

Immediate

Expiry Date

03 Dec, 25

Salary

0.0

Posted On

03 Sep, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Good communication skills

Industry

Mechanical or Industrial Engineering

Description

Responsibilities:

  • Perform supplier qualifications, action plans, audits, performance monitoring, supplier improvements, supplier capacity & capability assessment and assisting key suppliers towards industrial standards of excellence Work with EMSi supplier around design control, design verification and validation activities, production & process controls, corrective & preventative action, complaints and risk assessment & management with cross functional teams, and product quality improvement using tools such as six sigma, DFR, etc.
  • Work with EMSi supplier to ensure availability of parts & equipment & provide updates as necessary Ensure timely test development or duplication Deliver the PPAP for all parts Work collaboratively with internal and external partners to generate Quality documentation Work with suppliers to ensure compliance to Quality requirements Perform design review between engineering & suppliers Supplier & process development Part quality plan (PQP) element determination (FAI, capability study, FMEA, control plan, Gage RR), approval & execution with supplier.

Requirements:

  • Prior quality, manufacturing, product quality, supplier quality, supplier development or engineering experience in manufacturing environment Data management/Excel Project management Analytical problem solving & management of complex tasks Leadership and influence High level of judgment Expertise in EMSi manufacturing process Experience in mechanical and electronics commodities a plus.
Responsibilities
  • Perform supplier qualifications, action plans, audits, performance monitoring, supplier improvements, supplier capacity & capability assessment and assisting key suppliers towards industrial standards of excellence Work with EMSi supplier around design control, design verification and validation activities, production & process controls, corrective & preventative action, complaints and risk assessment & management with cross functional teams, and product quality improvement using tools such as six sigma, DFR, etc.
  • Work with EMSi supplier to ensure availability of parts & equipment & provide updates as necessary Ensure timely test development or duplication Deliver the PPAP for all parts Work collaboratively with internal and external partners to generate Quality documentation Work with suppliers to ensure compliance to Quality requirements Perform design review between engineering & suppliers Supplier & process development Part quality plan (PQP) element determination (FAI, capability study, FMEA, control plan, Gage RR), approval & execution with supplier
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