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Jobs / Medical Device Quality Engineer in United States of America
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Polarsemi·1 day ago
1 day agoBe an early applicant

Quality Systems Engineer

Bloomington, United States of AmericaMid · 2+ yearsMedical Device Quality Engineer

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Top 10% of NextRaise users matched against Medical Device Quality Engineer roles in United States.

Must-have skills for this role

  • iso 9001
  • quality management system
  • qms
  • supplier quality

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Apply faster with autofill FREEThe NextRaise extension autofills your application in one click.careers.example.com/applyAutofillingFull namePriya SharmaEmailpriya.sharma@example.comPhone+49 30 1234567LocationBerlGet the extension

What you'll do

  • Monitor, evaluate, and improve elements of the company Quality Management System (QMS).
  • Administer and improve the Supplier Quality program.
  • Audit suppliers’ QMS (3-5 travel opportunities annually).
  • Monitor incoming material quality.
  • Evaluate supplier conformance to requirements and rate suppliers’ performance.
  • Maintain material specifications.
  • Manage and improve the Change Management process.
  • Participate in and eventually manage the Internal Audit program, including leading internal audits.
  • Provide guidance and training as needed to company personnel, on QMS topics such as risk management, failure modes and effects analysis (FMEA), documentation, change management, QMS standards conformance, quality awareness, problem solving, corrective and preventive action.
  • Participate in and, if necessary, organize, mentor, and lead problem solving, process mapping, and quality improvement activities.
  • Write, maintain and improve documented procedures to support the QMS.
  • Prepare and present quality related materials in various quality venues: Quality reviews, Quality Management System audits, customer visits/audits, vendor visits, etc.

What they're looking for

  • Degree in Engineering or related technical field (or significant experience with the duties and responsibilities of the role in combination with demonstrated analytical abilities)
  • Effective oral and written communications
  • Critical thinking, problem solving, data analysis

Nice to have

  • 2+ years of experience at an organization certified to ISO 9001
  • Experience at an organization certified to IATF 16949 or AS9100
  • Experience in the semiconductor/microelectronics manufacturing industry
  • Experience as a Lead Auditor
  • Experience with or knowledge of Six Sigma, Design of Experiments (DOE), Failure Modes and Effects Analysis (FMEA), 5S, Poka-Yoke (error proofing), 8D problem solving, Root Cause Analysis methods (Five Why, etc.), Project Management, Continuous Improvement, Risk Management

Summarised by NextRaise from the employer’s description, which follows in full below.

Full description from employer

JOB DESCRIPTION:

Develop, implement, maintain and improve company quality systems in conformance with the ISO 9001, IATF 16949 and AS9100 Quality Management System standards.

DUTIES AND RESPONSIBILITIES:

  • Monitor, evaluate, and improve elements of the company Quality Management System (QMS).
  • Administer and improve the Supplier Quality program. Audit suppliers’ QMS (3-5 travel opportunities annually). Help suppliers develop and improve their QMS in accordance with Polar Semiconductor expectations. Monitor incoming material quality. Evaluate supplier conformance to requirements and rate suppliers’ performance. Maintain material specifications.
  • Manage and improve the Change Management process. Chair change review meetings, track change status, ensure conformance with the documented process.
  • Participate in and eventually manage the Internal Audit program, including leading internal audits. Training will be provided.
  • Provide guidance and training as needed to company personnel, on QMS topics such as risk management, failure modes and effects analysis (FMEA), documentation, change management, QMS standards conformance, quality awareness, problem solving, corrective and preventive action.
  • Participate in and, if necessary, organize, mentor, and lead problem solving, process mapping, and quality improvement activities.
  • Write, maintain and improve documented procedures to support the QMS.
  • Prepare and present quality related materials in various quality venues: Quality reviews, Quality Management System audits, customer visits/audits, vendor visits, etc.
  • Plan and prepare for annual 3rd party registrar audits. Host external auditors.
  • Support company initiatives and perform other duties as required.
  • Some aspects of the role can be tailored to the experience and interest of the successful candidate.
  • Hours are flexible with an emphasis on primary business hours. A hybrid work schedule is allowed.

SKILLS AND KNOWLEDGE:

  • Effective oral and written communications.
  • Critical thinking, problem solving, data analysis.
  • Typically requires a degree in Engineering or related technical field. Significant experience with the duties and responsibilities of the role in combination with demonstrated analytical abilities may be considered in lieu of a technical degree.
  • 2+ years of experience at an organization certified to ISO 9001 is preferred. Experience at an organization certified to IATF 16949 or AS9100, and/or in the semiconductor/microelectronics manufacturing industry, would be advantageous.
  • Experience with or knowledge of some of the duties and responsibilities of the role is preferred. Experience as a Lead Auditor would be advantageous.
  • Experience with or knowledge of any of the following would be advantageous: Six Sigma, Design of Experiments (DOE), Failure Modes and Effects Analysis (FMEA), 5S, Poka-Yoke (error proofing), 8D problem solving, Root Cause Analysis methods (Five Why, etc.), Project Management, Continuous Improvement, Risk Management.

The estimated base salary range for the position is $83,000- $121,000.  The pay offered is based on many factors including, but not limited to, relevant education, job-related experience, skills and level of the position.

Company

Polarsemi
Bloomington, United States of America

Company facts come from this company's own listings. We only show what the postings themselves carry.

Sourced from Polarsemi's careers site·first seen 22 Sept 2026·last verified 22 Sept 2026·How we source jobs

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