We are looking for a dedicated and detail-oriented Orthotic Lab Quality Control Manager to oversee our quality control processes and procedures in our O&P lab. The Orthotic Lab Quality Control Manager will be responsible for overseeing laboratory operations and ensuring product quality, adherence to quality assurance protocols, and maintaining a safe and efficient working environment. This role offers an exciting opportunity to lead a team of technicians and contribute to the success of our company in the O&P industry.

Responsibilities:

• Become highly proficient in all aspects of brace fabrication, able to train new hires
• Provide leadership, training, and mentorship to laboratory staff (4 employees), and foster a culture of collaboration, innovation, and continuous improvement.
• Develop and foster healthy working relationships between team members, managing any team conflict.
• Delegate tasks daily to team with clarity for maximum productivity.
• Ensure fabrication schedule is followed and problem-solve time sensitive changes.
• Develop and implement training program (in-house apprenticeship levels), including standard operating procedures (SOPs) and protocols for laboratory processes.
• Develop and implement quality control policies, procedures, and standards to ensure product quality and compliance with regulatory requirements.
• Conduct quality inspections, tests, and audits of finished products to verify conformance to specifications and standards.
• Oversee all lab fabrication processes: STL creation, sending to carver, pulls, rough brace cuts, grinding, buffing, casting, pouring molds, pad and strap prep.
• Investigate and resolve quality issues, deviations, and non-conformances, and implement corrective and preventive actions (CAPAs) as necessary.
• Collaborate with cross-functional teams including: Orthotic Fabrication Manager, Fabrication Coordinator, CAD Design Team, Office Manager and upper management to address quality-related issues and drive continuous improvement.
• Maintain documentation and records related to quality control activities, including test results, inspection reports, and quality metrics.

Qualifications:

• Bachelor’s degree or relevant technical experience
• Previous experience in quality control and laboratory management or leadership roles, preferably in the medical device or biotechnology industry.
• Previous experience successfully managing team dynamics.
• Excellent problem-solving, analytical, and decision-making skills.
• Strong knowledge of quality management systems, regulatory requirements, laboratory techniques and safety protocols.
• Ability to work effectively in a fast-paced and dynamic environment.
• Attention to detail and ability to work independently and as part of a team.

The expected salary range for this position is $90,000 – $110,000 per year, depending on experience and qualifications. Exceptional candidates with advanced medical device or orthotics lab leadership experience may be considered above this range.
Benefits:
· After 1 month: Health & Dental
· After 1 year: 401(k) with a company matching contribution
· Vacation and Sick Paid Time Off
· Schedule: Monday to Friday 9am-6pm
· No remote work
· Job Type: Full-time
KEYWORDS: material engineering, mechanical engineering, bioengineering, manufacturing, fabrication, hands-on, healthcare, orthotics, prosthetics, medical device
Job Type: Full-time
Pay: $90,000.00 - $110,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off

Ability to Commute:

• San Mateo, CA (Preferred)

Ability to Relocate:

• San Mateo, CA: Relocate before starting work (Preferred)

Work Location: In perso

• Become highly proficient in all aspects of brace fabrication, able to train new hires
• Provide leadership, training, and mentorship to laboratory staff (4 employees), and foster a culture of collaboration, innovation, and continuous improvement.
• Develop and foster healthy working relationships between team members, managing any team conflict.
• Delegate tasks daily to team with clarity for maximum productivity.
• Ensure fabrication schedule is followed and problem-solve time sensitive changes.
• Develop and implement training program (in-house apprenticeship levels), including standard operating procedures (SOPs) and protocols for laboratory processes.
• Develop and implement quality control policies, procedures, and standards to ensure product quality and compliance with regulatory requirements.
• Conduct quality inspections, tests, and audits of finished products to verify conformance to specifications and standards.
• Oversee all lab fabrication processes: STL creation, sending to carver, pulls, rough brace cuts, grinding, buffing, casting, pouring molds, pad and strap prep.
• Investigate and resolve quality issues, deviations, and non-conformances, and implement corrective and preventive actions (CAPAs) as necessary.
• Collaborate with cross-functional teams including: Orthotic Fabrication Manager, Fabrication Coordinator, CAD Design Team, Office Manager and upper management to address quality-related issues and drive continuous improvement.
• Maintain documentation and records related to quality control activities, including test results, inspection reports, and quality metrics