Senior Quality Manager

This position is responsible for managing quality systems, including audits, compliance with regulatory standards, and oversight of product release and corrective actions. The role requires strong leadership, regulatory knowledge, and experience in a highly regulated manufacturing environment.

Client Details

This organization is a leading innovator in the medical device sector, focused on delivering high-quality solutions that improve patient outcomes. Known for its commitment to regulatory compliance and advanced manufacturing practices, it fosters a culture of continuous improvement and collaboration. The company emphasizes quality, safety, and reliability across all operations, supporting global healthcare standards.

Description

• Develop and implement quality assurance systems and standards.
• Lead quality improvement initiatives within the Engineering & Manufacturing department.
• Ensure compliance with regulatory and industry-specific standards.
• Conduct regular audits and inspections to maintain quality benchmarks.
• Collaborate with cross-functional teams to address quality challenges.
• Provide training and mentorship to team members on quality practices.
• Analyze data to identify trends and implement corrective actions.
• Prepare and present quality performance reports to senior management.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Profile

• Bachelor's degree in a relevant field; formal training in quality tools (CQE, CQA, Six Sigma) is a plus.
• Experience in a regulated medical device manufacturing environment, including process and equipment validation.
• Strong knowledge of global medical device regulations and standards (e.g., 21 CFR 820, ISO 13485, EU MDR).
• Proven ability to lead quality initiatives, audits, and represent the quality function across manufacturing and engineering activities.

Job Offer

• Competitive salary ranging from $165000 to $195000.
• Comprehensive benefits package.
• Opportunities for professional growth within a respected organization.
• Supportive work environment with a focus on quality and excellence.

If you are passionate about quality management and want to excel in a challenging role, we encourage you to apply!

Desired Skills and Experience

- Bachelor's degree in a relevant field.
- Experience in regulated medical device manufacturing.
- Strong knowledge of global quality regulations (ISO 13485, 21 CFR, EU MDR).
- Proficiency in quality tools (CQE, CQA, Six Sigma) and root cause analysis.
- Expertise in audits, CAPA, and QMS management.
- Leadership and communication skills for cross-functional collaboration.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.