Job Opportunity: Quality Assurance Lead

Location: Westminster, CO
Type: Direct Hire through Job Store Professional
Salary: $120k-$130k

About the Role:
Join us in leading the charge to achieve ISO13485 certification! We're seeking a dynamic Quality Assurance Lead to drive high standards in our manufacturing processes. This is your chance to make a significant impact by implementing cutting-edge quality practices and working closely with our contract manufacturing partners.

Key Responsibilities:

• Spearhead ISO13485 certification efforts and compliance practices.
• Collaborate with cross-functional teams to ensure top-quality output.
• Develop and monitor quality and reliability metrics.
• Lead root cause analysis and corrective action initiatives.
• Implement Failure Modes and Effects Analysis (FMEA).
• Drive continuous improvement through quality tools like FMEA and SPC.
• Conduct internal and external quality audits.

Qualifications:

• 5+ years in an ISO certified manufacturing environment.
• Proven track record leading ISO13485 certification processes.
• Expertise in CAPA processes, FMEA, and Root Cause Analysis.
• Lean/Six Sigma/SPC certifications preferred.
• Strong communicator with a focus on continuous improvement.
• Bachelor’s degree in a related field and ISO13485 3rd party certification.

Apply today and lead our quality assurance to new heights!