Quality Manager

Scanlan International, Inc., is a medical device company specializing in the highest-quality surgical instruments. Now in our fourth generation, the Scanlan family continues its dedication to providing the best surgical instrumentation available anywhere in the world. We are seeking a Quality Manager to join our organization and continue this commitment.

The Quality Manager is responsible for implementing and maintaining state-of-the-art quality practices and assumes overall responsibility in ensuring that the quality system is in a state of compliance to domestic and international standards. The role is responsible for the organization, documentation and maintenance of the quality system to be compliant with ISO 13485, MDSAP, EU MDR and other applicable regulatory standards.

This role is focused on quality system improvement, supplier quality, quality audits, quality control, and quality system compliance. The Quality Manager has the responsibility, duty and decision‑making authority to put any product on hold that is identified as potentially non-conforming and escalating as needed for additional reviews by Technical teams.

This position is based out of our headquarters office, south of downtown St. Paul. We welcome an on‑site work environment Monday through Friday.

A QA Specialist and a team of Quality Control Technicians report to this position.

This role may require domestic travel up to 5–10% of the time.

Maintain the effectiveness of the Quality Management System (40%)

• Maintain state‑of‑the‑art competency of relevant quality management system requirements and standards via training and certification records.
• Ensure measurement, analysis, and improvement processes are effective, meet quality goals and objectives, and reported to management at regular intervals.
• Collect and analyze information, identify and investigate existing and potential causes of product and quality system problems and take appropriate corrective and preventive actions.
• Coordinate quality system certification and auditing activities with the Notified Body and other regulatory agencies.
• Coordinate internal and supplier quality audit activities.

Ensure production processes remain qualified and validated (30%)

• Ensure packaging and sterilization processes are validated, with periodic revalidation as required for compliance.
• Verify that appropriate controls are in place for the routine production of sterile medical devices, such as cleaning, packaging, sterile processing, cleanroom monitoring, storing, and handling.
• Review and approve production process validations, re‑validations, dose audits, lab test data/reports, etc. to ensure sterile medical devices remain safe.

Manage quality control inspection, acceptance, and release activities (10%)

• Define quality control sampling plans using sound statistical methods that ensure the confidence and reliability levels required by the risk analysis.
• Ensure inspection test, and measurement equipment/techniques are calibrated and capable of producing repeatable/reliable data to ensure conformance to specifications.
• Ensure inspection and test activities are planned to ensure requirements are met.
• Ensure segregation of nonconforming products to avoid mix‑ups.
• Ensure quality records are verified and approved, indicating that devices manufactured meet quality requirements.

Lead nonconforming material process (10%)

• Ensure nonconforming materials are quarantined, identified, documented, and processed via MRB in a timely manner.
• Assist cross‑functional teams in the investigation, review, and actions regarding nonconforming materials.
• Ensure effective communication with all parties impacted by the NCMR.
• Coordinate risk review and any required regulatory actions with regulatory affairs.
• Provide quality leadership to the Material Review Board (MRB) to ensure prompt and appropriate disposition of nonconforming products.
• Perform supplier quality trend analysis and reports.

Manage document control and quality records and assist with tasks as needed by the manager (10%)

• Ensure quality system documents meet business and regulatory requirements.
• Ensure required documentation is reviewed…