Quality Manager

Job Description

Job Description

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.

What You'll Do As a Quality Manager :

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%)

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

Lead nonconforming material process (10%)

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

The Experience, Skills and Abilities Needed :

Required

Preferred

Other

Compensation

We are committed to equitable and transparent pay practices. The salary range for this position is $96,200 - $154,000, representing the minimum and maximum of our compensation structure. Starting pay will typically fall between these values and is determined based on factors such as relevant experience, skills, and internal equity. Offers near the higher end of the range are reserved for candidates with exceptional qualifications.

Comprehensive Benefits Offerings

How to Apply?

Scanlan International, Inc. accepts online applications at https : / / www.scanlaninternational.com / contact -us / careers /

Applicants with disabilities who need accommodation to complete the Scanlan International, Inc. application process should contact Human Resources at 1.800.328.9458 or email hrteam@scanlangroup.com.

Scanlan International is an EEO employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please click the following link to view Federal and E-Verify posters : https : / / www.e- verify.gov / employees