Schedule: Monday – Friday, 7:00AM – 4:00 PM (Some flexibility available based on production needs)

‍

About Us:

‍Sincera Talent Partners is collaborating with an industry-leading medical device manufacturer in Phoenix, AZ, seeking a Quality Assurance Manager to oversee compliance, quality systems, and process improvements in a regulated, FDA-compliant environment. This role is crucial in ensuring that all products meet ISO13485, FDA, and GMP standards, while fostering a culture of continuous improvement and inclusion.

‍

Who We’re Looking For:

‍An experienced quality leader who thrives in a fast-paced manufacturing environment and understands the critical role of quality in patient safety and regulatory compliance. You are an advocate for process excellence, team development, and cross-functional collaboration.

‍

What You’ll Do:

• ‍Quality System Leadership: Manage and continuously improve ISO 13485-compliant QMS, ensuring alignment with FDA, GMP, and MDR requirements.
• ‍Audit & Compliance: Lead internal and external audits (FDA, ISO, customer audits) and ensure timely resolution of findings.
• ‍Process Improvement: Implement Lean Six Sigma methodologies to enhance quality processes, reduce waste, and increase efficiency.
• ‍Supplier & Manufacturing Quality: Oversee incoming inspection, supplier quality programs, and production quality control to maintain high standards.
• ‍CAPA & Non-Conformance Management: Drive root cause analysis and corrective action processes to resolve quality issues.
• ‍Training & Team Leadership: Mentor and develop a diverse team of quality engineers, technicians, and inspectors, ensuring an inclusive, growth-oriented environment.
• ‍Cross-Functional Collaboration: Work closely with R&D, Manufacturing, and Regulatory Affairs to ensure quality is embedded throughout the product lifecycle.
• ‍Customer & Regulatory Reporting: Respond to customer complaints, field failures, and regulatory inquiries, ensuring proper documentation and follow-up.

‍

Must-Have Qualifications:

• ‍7+ years of experience in quality assurance within medical device manufacturing.
• In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, and GMP regulations.
• Experience leading FDA, ISO, and supplier audits with a track record of successful compliance.
• Strong background in CAPA, risk management, and root cause analysis.
• Ability to implement and improve QMS software systems for documentation control.
• ‍Leadership experience managing quality teams in a fast-paced production environment.
• Excellent problem-solving and communication skills, with the ability to engage diverse teams.

‍

Nice-to-Have Qualifications:

• ‍‍Bachelor’s degree in Engineering, Quality Management, or related field.
• Experience with process validation (IQ, OQ, PQ) and statistical analysis (SPC,DOE).
• Familiarity with automated inspection systems and Industry 4.0 quality technologies.

‍

What We Offer (Benefits & Culture):

• Competitive Salary + Performance Bonuses
• 401(k) Matching & Comprehensive Health Benefits
• Career Growth & Professional Development Programs
• Inclusive Workplace with Employee Resource Groups (ERGs) & DEI Initiatives
• Flexible Work Arrangements & Paid Time Off

‍

We believe diverse perspectives drive innovation. If you’re a quality leader passionate about improving medical device manufacturing, we’d love to hear from you!

‍

Sincera Talent Partners is dedicated to fostering a diverse and inclusive environment. We are proud to be an equal opportunity employer, and we only partner with companies that share our commitment to diversity, equity, and inclusion. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We are committed to creating a workplace that values and respects individuals from all backgrounds and experiences.

‍

‍