Quality Supervisor

Exceptional People. Hard Problems. Meaningful Careers. Big Impact.

Nowhere else can you touch as many life-changing medical technologies. At Forj Medical, we work side by side with more than 100 medical device companies from startups to global giants to bring life-enhancing technologies to market. Working with us means solving hard problems with extraordinary people in a collaborative work environment. Join us.

The Quality Supervisor leads the strategic direction, execution, and continuous improvement of all Quality Control (QC) operations within Forj Medical. This role ensures that all products meet global regulatory, safety, and performance standards, while driving long-term quality strategy, operational excellence and risk reduction. The leader in this role oversees multiple QC teams (incoming, in-process, final testing) across 3 sites, collaborates closely with executive leadership, and plays a key role in driving operational excellence.

• Develop and implement a long-term QC strategy aligned with corporate goals, product roadmap, and global compliance requirements.
• Serve as a key member of the Quality Leadership team, contributing to organizational strategy, quality planning, and resource allocation.
• Establish enterprise-wide QC standards, metrics, and performance benchmarks to ensure robust and scalable quality systems.
• Ensure full compliance with all compliance and regulatory requirements including ISO 13485, FDA, and 21 CFR Part 820.
• Ensure team is completing all requirements of qualification plans (IQ, OQ, PQ) and reports to assure components, materials and suppliers meet specified requirements and performance, reliability and safety goals.
• Lead and supervise all QC functions including incoming inspection, in-process testing, final QC release, stability testing, and lab operations.
• Oversee creation, revision, and approval of SOPs, work instructions, specifications, and control plans.
• Lead QC readiness for audits; act as SME (subject matter expert) for QC processes.
• Ensure state-of-the-art testing methodologies, equipment qualifications, and data integrity practices.
• Support design transfer, new production introductions (NPI), and process validation activities.
• Ensure robust root cause analysis, CAPA development, and timely closure of quality events.
• Additional duties as assigned.

Bachelor’s degree in quality engineering or related field or equivalent work experience.

• Bachelor’s degree in quality engineering or related field or equivalent work experience.

• Three to five years of experience in quality management, quality, or manufacturing engineering.
• Experience in an ISO 13485 Medical Device Quality System is required.

• Deep knowledge of global medical device regulations.
• Strong background in product testing, statistical methods, and quality engineering principles. Ability to lead change in complex and fast-paced manufacturing environments.
• Leadership in supporting regulatory audits and driving cross-functional alignment.
• Strong problem-solving skills, root cause analysis and corrective action investigations are a must.
• Lean Sigma experience desired. CQE certification is a plus.
• Working knowledge of Minitab statistical software, a plus.

Physical demands described here are representative of those that must be met by an employee to successfully perform essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing duties of this Job, employee is regularly required to use hands to finger, handle, or feel. Employee is frequently required to stand;

walk; sit and talk or hear. Employee is occasionally required to reach with hands and arms. Employee must frequently lift and/or move up to 10 pounds.

The above statements are intended to describe the general nature and level of work performed by employees assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such…