Quality Manager

Jobot; Totowa (NJ); On-site; USD 110,000 - 130,000; Full time

Job summary

Jobot is seeking a Quality Manager for a leading medical device manufacturer in Totowa, NJ. The role focuses on managing the QMS, ensuring compliance with QSR and ISO standards, and leading a team of quality professionals.

Ideal candidates will have 7+ years in medical devices with engineering or scientific training, and hold CQE/QA/Lead Auditor certifications. Salary ranges up to $130,000 with strong benefits and career growth opportunities.

Qualifications

• Bachelor’s degree in Engineering or related field with 7+ years of experience, or Master’s with 5+ years.
• Certified Quality Engineer, Certified Quality Auditor, or Certified Lead Auditor.
• Six Sigma Green Belt desirable; Lean and 5S training desirable.
• Experience in the medical device field; familiarity with machining, metal finishing, and orthopedics.

Responsibilities

• Manage and continuously develop the QMS in compliance with medical device industry requirements.
• Ensure compliance with FDA QSR, ISO 9001, ISO 13485, and ISO 14971 standards.
• Oversee audits, CAPA, complaint handling, document/change control, and design control.
• Lead supplier quality activities including supplier controls, process development, and validation.
• Provide technical and statistical support to QC teams and data analysis.
• Drive continuous improvement in quality, efficiency, and operational performance.

Skills

QMS leadership

Quality control

CAPA management

Statistical analysis

Education

Bachelor’s degree in Engineering or related science

Master’s degree in Engineering or related field

Certified Quality Engineer

Certified Quality Auditor

Certified Lead Auditor

Six Sigma Green Belt

Lean and 5S training

Job description

Quality Manager Needed For Leading Medical Device Manufacturer

Salary: $110,000 - $130,000 per year

A bit about us:

My client is a leading medical device manufacturer and they are growing! They are looking to add a Quality Manager to their team who manage and monitor performance of all aspects of quality assurance and quality control. The ideal candidate will demonstrate a firm understanding of quality management systems specifically focused in the medical device field. Expert understanding of the QSR, ISO 9001, ISO 13485, control plans, and ISO 14971 are required.

Why join us?

Compensation Up To $130,000

Job Details

Job Duties:

• Manage, implement, and continuously develop the company’s Quality Management System (QMS) in compliance with medical device industry requirements.
• Ensure compliance with FDA Quality System Regulation (QSR), ISO 9001, ISO 13485, and ISO 14971 standards and requirements.
• Oversee quality system activities including CAPA, complaint handling, document control, change control, and design control.
• Manage internal and external audits, including preparation, execution, findings, corrective actions, and follow-up activities.
• Provide quality support for supplier development, supplier controls, process development, and process validation activities.
• Develop and maintain control plans and quality procedures to ensure consistent product and process compliance.
• Apply knowledge of Good Laboratory Practices (GLP), sterilization equipment, sterilization methods, and related procedures.
• Provide technical and statistical support to Quality Control teams, including data analysis, process monitoring, and problem resolution.
• Support continuous improvement initiatives focused on quality, efficiency, compliance, and overall operational performance.
• Lead and manage quality personnel, including workload planning, performance management, technical mentoring, and development of team members.

Education:

• A minimum of a Bachelor’s degree in Engineering or a relevant scientific discipline with a focus 7 years of relevant experience, or a Master's degree in the same with 5 years of experience is required.
• Appropriate certifications may include Certified Quality Engineer, Certified Quality Auditor, and Certified Lead Auditor.
• Six Sigma Green Belt is desirable.
• Training in Lean and 5S are desirable.

Experience:

• Minimum of 5 years’ experience in the medical device field in roles such as quality engineer, quality control supervisor, auditor, quality assurance, quality manager.
• Familiarity with machining, metal finishing, sheet metal fabrication and assembly processes.
• Familiarity with the orthopedic industry.

Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions.

Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.