Quality Manager (Medical Device)

Judge Direct Placement; Detroit (MI); On-site; USD 110,000 - 165,000; Full time

Job summary

A leading company in the medical device industry seeks a Quality Systems Manager to develop and implement quality management systems in accordance with ISO 13485 standards. The selected candidate will mentor the quality engineering team, ensuring compliance with regulatory requirements in a fast-paced environment. Candidates must have significant experience in the medical device field and demonstrate strong leadership qualities.

Benefits

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Qualifications

• 5+ years of experience in the medical device industry.
• Proven track record of working under ISO 13485 standards.

Responsibilities

• Develop and maintain quality management systems in accordance with ISO 13485.
• Oversee compliance with medical device regulations.
• Train and coach teams on QA processes.

Skills

Communication

Interpersonal Skills

Education

Bachelor degree in Engineering or relevant Life Science discipline

Job description

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Judge Direct Placement provided pay range

This range is provided by Judge Direct Placement. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$110,000.00/yr - $165,000.00/yr

Direct message the job poster from Judge Direct Placement

Judge Direct Placement is exclusively partnering with our client in the medical device industry on their Quality Systems Manager position. The ideal candidate will have a strong background in the medical device industry and an in-depth understanding of ISO 13485 standards. As a servant leader, you will be responsible for mentoring the quality engineering team, maintaining our quality systems and ensuring compliance with all regulatory requirements.

Key Responsibilities:

• Develop, implement, and maintain quality management systems in accordance with ISO 13485 standards.
• Serve as the primary quality representative for existing and prospective customers.
• Oversee compliance with medical device regulations, including MDR 2017/745/EU, FDA 21 CFR Part 820, and ISO 13485.
• Review and consolidate product requirements for medical device systems according to applicable regulations.
• Actively contribute to defining medical device documentation, from user needs to design verification testing.
• Work closely with Clinical Affairs to set up quality files suitable for pre-market clinical investigation.
• Collaborate with the Legal team to prepare manufacturing and quality agreements with external providers and suppliers.
• Perform quality audits and maintain all quality documentation related to products.
• Train and coach teams to use, follow, and work under QA processes.
• Oversee the risk management process and related activities.

Required Experience:

• A minimum of 5 years of experience in a similar position within the medical device industry.
• Proven track record of working under ISO 13485 quality management systems.

Qualifications:

• Bachelor degree in Engineering or relevant Life Science discipline.
• Detailed understanding USA medical device regulations.

Leadership Style:

• Must embody the principles of servant leadership, prioritizing the growth and well-being of team members and the communities to which they belong.
• Strong communication and interpersonal skills to lead and inspire the team.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance, Engineering, and Management

• Industries

  Medical Equipment Manufacturing, Manufacturing, and Primary Metal Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

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