Quality Engineer


Minnesota Lake, MN

Industry: Engineering Services


Not Specified years

Posted 379 days ago

  by    Bajrang Yadav

This job is no longer available.

Job Title: Quality Engineer II

Location : Minnesota,MN

Job Description:(Please Ignore if not good match)



This position is responsible for the Supplier Chain Quality Engineering activities for implantable components (raw material, parts, sub-assemblies and assemblies) and contract manufactured product related to New Product Introduction (NPI) of DBS, Pain, and Pelvic Health therapies.

This includes supplier evaluation and selection, supplier process development, demonstrating capability and stability of supplier processes, qualification of supplier product, and readiness for production in a high-volume manufacturing or contract manufacturing facility.

Primary Skills:

Highly proficient in writing technical documents using word-processing software

Experience with data analysis/statistical software applications such as MiniTab or equivalent

Experience working process validation IQ/OQ/PQ 

Provide Supplier Quality Engineeringsupport to product development programs responsible for new medical device products

Provide input to and align activities to development project schedule

Provide technical expertise during supplier evaluation and selection

Lead efforts to prepare external component supplier's product from development through production release

Determine the required supplier process development/validation and qualification activities and partner with Supply Chain to communicate requirements to the suppliers

Ensure documentation is completed per quality system procedures for supplier process

development/validation and product qualification

Establish controls (process, product, inspection) at the supplier based on risk input

Provide status updates as required per assigned projects

Apply QSR 21CFR Part 820 (Medical Devices) to everyday application of Supplier Quality Engineering activities

Define, establish and implement supplier quality assurance processes for medical device product

Participate in internal and supplier audits.

Experience in an engineeringsupport role in a manufacturing factory environment of metal forming, plastic forming/extrusion, chemical processing, foundry or wire coating

Experience with Finished Device Kit Manufacturers including Final Pack and ETO Sterilization

Experience with Test Method Validation (Measurement Systems Analysis, Gage R&R, correlation and uncertainties) including gage and fixture design

Ability to independently travel to supplier locations around the world without restriction. Able to obtain appropriate travel documents

Secondary Skills:

Knowledge, understanding and implementation experience with medical device quality systems, manufacturing operations, supplier quality, and regulatory requirements Experience in program or project leadership and the associated communication, presentation, team facilitation, and influence management skills

Ability to communicate effectively in multi-discipline, cross cultural environment and levels of organization

Prior experience in a medical device

Educational Qualifications

Bachelor's degree in Engineering or related field of science