Senior Product Quality & Regulatory Lead

Tecomet; Lansing (MI); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Competitive pay

Health benefits starting day one

401k with company match

Paid holidays

PTO

Job summary

Tecomet in Lansing, Michigan is seeking a Sr. Quality and Regulatory Affairs Manager to lead the Quality Engineering team and drive product quality improvements across two manufacturing facilities.

This role emphasizes cost of quality, data-driven decision making, risk-based thinking, and regulatory compliance with standards such as ISO 13485 and FDA QSR while aligning with corporate goals.

Qualifications

• :
• Bachelor’s degree in engineering or a scientific discipline.
• 3+ years of experience in a similar leadership role, including managing engineering or quality teams.
• Experience within a highly regulated manufacturing environment (medical device, pharmaceutical, aerospace & defense, or automotive).

Responsibilities

• Lead and develop the Quality Engineering team.
• Own Product Quality performance and Cost of Quality (CoQ) metrics.
• Define and implement methods for product quality data capture and analysis.
• Develop and deploy Cost of Quality metrics at multiple levels.
• Drive strategic quality planning with a focus on quality-at-the-source.
• Interface with customers, NPI/Engineering, and Manufacturing/Operations.

Skills

Leadership

Quality management

Regulatory thinking

Stakeholder management

Education

Bachelor’s degree in engineering or scientific discipline

Tools

PFMEA

APQP

Control plans

Validation methodologies

Job description

Tecomet in Lansing, Michigan is seeking a Sr. Quality and Regulatory Affairs Manager to lead the Quality Engineering team and drive product quality improvements across two manufacturing facilities.

This role emphasizes cost of quality, data-driven decision making, risk-based thinking, and regulatory compliance with standards such as ISO 13485 and FDA QSR while aligning with corporate goals.