Sr. Quality and Regulatory Affairs Manager

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

Sr. Quality and Regulatory Affairs Manager

#600

Position Type

Full-time

Travel Requirements

None

Job Description

Sr. Quality Manager (Product Quality)

Build innovative solutions and design the future . You can pursue your potential at Tecomet by working with a dedicated team to solve complex challenges, in partnership with industry-leading clients in medical device technology, aerospace, and defense industries. With the backing of our steadfast brand, you can be a part of the next era of manufacturing by bringing bold ideas to life and building products that improve on the status quo.

What’s In It For You:

At Tecomet, we believe that everyone makes a difference and contributes to our overall success. We are a team bound together by pride in our work and dedication to our craft. Our leadership team shares the company’s strategic direction so our workforce can remain informed and attain our internal goals and objectives.

Let’s talk about what we have to offer:

• Competitive pay and benefit packages
• Health Benefits start on day one
• 401k available with company match
• 9 Paid Holidays with 2 Floating Holidays
• PTO offered
• Be part of a global organization with strong growth in high-tech, high-impact industries
• Lead a high-visibility function that directly impacts product quality and customer success
• Shape and advance product and process quality strategies across multiple sites
• Clear opportunities for career progression , with exposure to global operations and pathways into senior leadership roles
• Collaborative culture focused on continuous improvement, innovation, and operational excellence

POSITION SUMMARY:

We are seeking a dynamic and strategic Quality Manager – Product Quality to lead a critical function within our Lansing, Michigan operations. This position supports two manufacturing facilities and plays a key leadership role in driving product quality, enhancing customer experience, and developing advanced quality practices.

Reporting to the Quality Director level, you will lead the Quality Engineering team, champion quality-at-the-source principles, and deliver measurable improvements in Cost of Quality (CoQ) and product performance. This role blends technical expertise, leadership capability, and business acumen, with high visibility across both site and organisation wide Operations, Engineering, and Customer-facing functions.

PRINCIPAL RESPONSIBILITIES:

• Lead and develop the Quality Engineering team, driving talent growth, capability building, and standardized ways of working.
• Own Product Quality performance, including:
• Cost of Quality (CoQ) development, tracking, and optimization
• Enhancing customer experience and satisfaction through quality excellence
• Define and implement methods for product quality data capture and analysis, enabling data-driven decision-making
• Develop and deploy Cost of Quality metrics at both business and manufacturing stream levels
• Drive strategic quality planning, with a strong focus on quality at the source and proactive defect prevention principals.
• Act as the primary interface between the Quality Engineering team and key stakeholders, including:
• Customers
• New Product Introduction (NPI) and Engineering teams
• Manufacturing and Operations
• Champion risk-based thinking, leveraging PFMEA as an active and embedded tool in operations
• Serve as a Subject Matter Expert (SME) in:
• Process validation principles and execution
• Advanced problem-solving methodologies (e.g., root cause analysis, structured problem solving)
• Change management processes within regulated environments
• Lead initiatives that strengthen cross-functional alignment and improve overall business performance

EDUCATION AND EXPERIENCE REQUIRED

Basic 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)

Preferred Skills & Experience

• Proven success in managing and improving Cost of Quality (CoQ) programs
• Strong understanding of product quality data systems and analytics
• Experience with APQP, PFMEA, Control Plans, and validation methodologies
• Familiarity with regulated quality standards (e.g., ISO 13485, AS9100, ISO 9001, FDA QSR)
• Proficiency in Microsoft Office Suite and experience with electronic systems/workflow tools
• Strong leadership and team development capability
• Excellent business acumen with the ability to align quality objectives to broader organizational goals
• Advanced communication and stakeholder management skills, including interaction with:
• Executive leadership
• Customers and regulatory bodies
• Engineering and operations teams
• Strategic thinker with hands‑on problem‑solving ability
• High level of accountability, ownership, and drive for results

Working Conditions

• Site-based role supporting multiple manufacturing facilities
• Regular interaction with cross‑functional teams, customers, and external stakeholders

Tecomet , Inc is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, gender identity, religion, sexual orientation, national origin, disability, genetic information, pregnancy, protected veteran status, or any other protected characteristic as outlined by federal, state, or local laws.

Tecomet is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, age, genetic information, national origin, or protected veteran status and will not be discriminated against on the basis of disability.