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72 Katalyst Principal Quality Engineer Jobs Hiring Near You

Katalyst

Principal Quality Engineer

Milwaukee, WI

We are seeking an experienced Principal Quality Engineer to lead quality engineering initiatives that ensure compliance, product quality, and continuous improvement across manufacturing and product ...

Katalyst

Principal Quality Engineer

Fort Smith, AR · On-site

We are seeking an experienced Principal Quality Engineer to lead quality engineering initiatives that ensure compliance, product quality, and continuous improvement across manufacturing and product ...

Katalyst

Principal Quality Engineer

Spokane, WA · On-site

We are seeking an experienced Principal Quality Engineer to lead quality engineering initiatives that ensure compliance, product quality, and continuous improvement across manufacturing and product ...

Katalyst

Principal Quality Engineer

Richmond, VA · On-site

We are seeking an experienced Principal Quality Engineer to lead quality engineering initiatives that ensure compliance, product quality, and continuous improvement across manufacturing and product ...

Hiscox

Principal Quality Engineer

Boston, MA · Hybrid

$120 - $140K/hr

Permanent Build a brilliant future with Hiscox Principal Quality Engineer We are seeking an innovative Principal Quality Engineer who will advance our testing capabilities through modern automation ...

Northrop Grumman Corp. (JP)

$98K - $148K/yr

Northrop Grumman Mission Systems Sector is seeking a Principal Quality Engineer / Sr. Principal Quality Engineer to join our team in Baltimore, MD . This position will support the AMC Restricted ...

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Katalyst appears to be a collaborative and innovative company that values creativity and teamwork, fostering an environment where employees can share ideas and work together to achieve common goals.

The company's structure and work environment seem to be designed to support a dynamic and agile approach, with a focus on delivering high-quality results and driving business growth. Katalyst's mission is centered around helping businesses and organizations succeed through strategic partnerships and tailored solutions.

Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.

What makes Katalyst an attractive place to work?

Katalyst is a forward-thinking company that has established itself as a leader in its industry, known for its commitment to innovation and customer satisfaction. The company's work environment is characterized by a collaborative and dynamic atmosphere, where employees are encouraged to share ideas and work together to drive progress. Joining Katalyst offers opportunities for professional growth and development, as well as the chance to contribute to meaningful projects that can have a lasting impact.

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Infographic showing various Principal Quality Engineer job openings at Katalyst in the United States as of September 2026, with employment types broken down into 97% Full Time, 2% Part Time, and 1% Nights. Highlights an 97% Physical, 1% Hybrid, and 2% Remote job distribution.

Principal Quality Engineer

Milwaukee, WI

Katalyst
See more jobs at Katalystexternal

Full-time

Re-posted 10 days ago

Job description

Job Description:
We are seeking an experienced Principal Quality Engineer to lead quality engineering initiatives that ensure compliance, product quality, and continuous improvement across manufacturing and product development processes. The ideal candidate will provide technical leadership in quality systems, risk management, validation, CAPA, supplier quality, and regulatory compliance while partnering with cross-functional teams to drive operational excellence.
Responsibilities:
  • Lead quality engineering activities supporting product development, manufacturing, and sustaining engineering.
  • Develop and implement quality strategies that comply with FDA, ISO 13485, ISO 9001, and other applicable regulatory requirements.
  • Drive root cause investigations and corrective and preventive actions (CAPA) using structured problem-solving methodologies.
  • Lead risk management activities including DFMEA, PFMEA, risk assessments, and mitigation plans.
  • Review and approve engineering change orders (ECOs), design documentation, validation protocols, and quality records.
  • Support design control activities including Design Verification & Validation (V&V), Design Reviews, and Design History Files (DHF).
  • Analyze quality metrics and implement continuous improvement initiatives using Lean Six Sigma and statistical tools.
  • Lead process validation activities including IQ, OQ, PQ, and process capability studies.
  • Collaborate with Manufacturing, R&D, Regulatory Affairs, Supply Chain, and Operations to resolve quality issues.
  • Provide technical leadership during internal, customer, and regulatory audits.
  • Mentor and coach Quality Engineers and cross-functional teams on quality best practices.
  • Support supplier qualification, supplier audits, and supplier quality improvement initiatives.
  • Ensure compliance with cGMP, FDA Quality System Regulation (21 CFR Part 820/QMSR), and applicable international standards.
Requirements:
  • Bachelor's degree in Engineering (Mechanical, Biomedical, Industrial, Manufacturing, Electrical, Chemical, or related discipline).
  • 8+ years of Quality Engineering experience in a regulated manufacturing environment.
  • Strong knowledge of FDA regulations, ISO 13485, ISO 9001, and cGMP requirements.
  • Experience with Design Controls, Risk Management (ISO 14971), CAPA, Client, and change management.
  • Hands-on experience with process validation (IQ/OQ/PQ), statistical analysis, SPC, MSA, and capability studies.
  • Strong knowledge of Lean Manufacturing, Six Sigma, and continuous improvement methodologies.
  • Excellent root cause analysis skills utilizing 8D, Fishbone, 5 Whys, and similar tools.
  • Experience leading cross-functional projects and mentoring engineering teams.
  • Strong written, verbal, and presentation skills.
Preferred Qualifications:
  • Master's degree in Engineering or related technical field.
  • ASQ Certified Quality Engineer (CQE), Six Sigma Green Belt or Black Belt.
  • Experience in medical devices, pharmaceuticals, biotechnology, aerospace, automotive, or other highly regulated industries.
  • Experience supporting FDA inspections and ISO certification audits.
  • Knowledge of validation documentation, statistical software (Minitab), and quality management systems.

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