Operations Quality Manager

Harleysville, PA

Full Time

Manager/Supervisor

Operations Quality Manager

Martech Medical Products, Inc.
Harleysville, PA

📍 On-site | Full-Time

About the Role

We are looking for a driven and experienced Operations Quality Manager to lead quality engineering and Quality Control functions within our medical device manufacturing operations. This role plays a critical part in ensuring product quality, regulatory compliance, and continuous improvement across the organization.
You will lead a team, partner cross-functionally, and ensure adherence to FDA, ISO 13485, and related standards in a cleanroom manufacturing environment.

What You'll Do

Quality Engineering

Lead risk management activities (PFMEA, control plans)
Support product development and design transfer (21 CFR Part 820)
Develop and validate inspection methods and test protocols
Analyze quality data (CAPA, NCRs, complaints) and drive root cause investigations
Partner cross-functionally with Engineering, Manufacturing, and Supply Chain
Interface with customers on quality issues

Quality Control Leadership

Supervise and develop QC team members
Oversee incoming, in-process, and final inspections
Manage nonconforming materials and participate in MRB
Ensure accuracy of Device History Records (DHRs)
Improve inspection processes and drive efficiency
Conduct non-conforming product investigations

Equipment & Validation

Manage inspection/test equipment lifecycle
Conduct IQ/OQ/PQ and MSA (Gage R&R) activities
Support new equipment introduction and automation initiatives

Compliance & Continuous Improvement

Ensure compliance with FDA, ISO 13485, ISO 14971
Support audits and drive timely corrective actions
Lead structured problem-solving (8D, 5 Whys, Fishbone)
Champion Lean/Six Sigma improvements

What You Bring

Required

Bachelor’s degree in Engineering, Quality, or related field
7+ years of quality experience in medical device or regulated manufacturing
Strong knowledge of FDA QSR and ISO 13485
Experience with CAPA, NCRs, inspections, and statistical tools
Leadership experience or demonstrated team leadership capability
Strong communication, analytical, and problem-solving skills

Preferred

ASQ certification (CQE, CQA)
Lean Six Sigma Green or Black Belt
Experience with ISO 14971 risk management
Familiarity with eQMS, CSV, and supplier quality
Proficiency with statistical software (Minitab, JMP)

Work Environment

On-site role in a combination of office, manufacturing, and cleanroom environments
Hands-on involvement with production and inspection processes
Occasional travel as needed

Important Requirements

✅ Must be legally authorized to work in the United States
✅ This is a fully on-site position (no remote or hybrid option)
❌ Current or future visa sponsorship is not available
❌ Relocation assistance is not available

Why Join Us

Opportunity to lead quality in a regulated, high-impact environment
Collaborative, cross-functional culture
Focus on continuous improvement and innovation
Career growth and leadership development opportunities

Our offerings have our Team Members’ well-being in mind

Competitive compensation
Health, Dental, Vision coverage
FSA
Life Insurance
401k
Generous PTO
Paid Holidays

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How many years of experience do you have working in the medical device industry?*

Have you ever worked in a regulated manufacturing environment?*

Are you legally authorized to work in the United States?*

Will you now or in the future require employment visa sponsorship to work in the United States?*

This position is 100% on-site in Harleysville, PA and is not eligible for remote or hybrid work. Are you willing and able to work on-site as required?*

Are you currently within commuting distance of Harleysville, PA, or willing to relocate at your own expense before your start date?*

What is your minimum annual base salary requirement?*

How many years of experience do you have leading quality programs in a manufacturing, distribution, or operations environment?*

How many years of experience do you have directly managing quality, operations, or cross-functional teams?*

Have you led root cause investigations and implemented corrective and preventive actions (CAPA)?*

Which quality management systems have you worked with?*

Do you have experience leading Lean, Six Sigma, Kaizen, or continuous improvement initiatives?*

Have you been responsible for monitoring and improving KPIs such as defect rates, customer complaints, audit findings, scrap, or cost of quality?*

Have you managed or participated in customer, regulatory, or certification audits?*

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VISION & MISSION STATEMENT

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Operations Quality Manager

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