Key Surgical LLC Company Logo Key Surgical LLC

Quality Manager - Med Device/Supply

Are you an experienced Quality Manager looking to join a growing international medical device/supply company with an exciting track record of growth? Come be an integral part of Key Surgical, leading our dynamic US Quality team. This critical position reports to our Global Director of Quality and Regulatory and is based out of our Eden Prairie office. If you have at least 5 years of experience with quality management systems in the medical supply/device market along with a passion for leading and developing a team, we’d like to hear from you!

Our Quality Manager is responsible for processes and documentation relating to quality assurance, including quality reporting, RGAs, customer complaints and CAPAs, validations, incoming goods, nonconforming material reports, SCARs, supplier controls and outsourced processes such as sterilization and product testing. The position works directly with applicable quality standards, internal and external auditors, and cross-functionally with product management, sales, operations and purchasing.

Key Responsibilities:

  • Oversee aspects of the quality management system and support documentation and processes
  • Report to Management on the performance of the quality management system and any need for improvement
  • Lead, manage, and develop the Quality Control, Quality Assurance and Supplier Quality staff including responsibilities for selection, coaching, performance management, and talent development of the team
  • Evaluate and sign off on CAPAs, quality plans, documentation, customer complaints, audits, validations, training, NCMRs and other quality feedback mechanisms
  • Review product documentation and records, including quality control test results, as needed (e.g., sterilization certificates, sterilization validations, routine dose audits, certificates of conformance) for the release of product
  • Develop product and process inspection plans and criteria
  • Recognize and handle product, process and quality system nonconformities
  • Maintain an in-depth understanding of the quality and documentation systems, applicable standards and requirements
  • Monitor process controls associated with all business functions to ensure compliance with the requirements and intent of the established ISO quality system
  • Maintain an awareness of Regulatory Affairs as it relates to and impacts Key Surgical and including the requirements for vigilance reporting
  • Conduct and approve audits: internal, external, and supplier
  • Conduct quality system training for company personnel as required to comply with quality system requirements
  • Review product documentation and records, including quality control test results, as needed (e.g., sterilization certificates, sterilization validations, routine dose audits, certificates of conformance) for the release of product
  • Recognize and handle product, process and quality system nonconformities

Education, Experience & Skills:

  • Bachelor's degree in business, science, or related technical field
  • 5 years' medical industry experience a must (medical device or medical 5 supply)
  • 5 years’ experience in Quality related systems
  • At least 3 years of experience managing a team
  • Ability to collaborate and communicate effectively within cross-functional teams
  • Solid knowledge and experience with electronic quality system management software
  • Ability to effectively prioritize, managing multiple projects with overlapping timelines
  • Solid communication, decision-making, and organizational skills
  • Ability to think critically and problem solve
  • Computer proficiency with Microsoft Office products required
  • Must be able to travel up to 15% including domestic and international trips

About Us:

We offer a positive employee focused culture, very competitive salary and benefits package including generous bonus, and excellent opportunities for career growth! Key Surgical is a leading provider of sterile processing, operating room, endoscopy and instrument care supplies. Committed to manufacturing and distributing the highest quality products, Key Surgical maintains the highest level of applicable ISO and FDA requirements. Continual dedication to personalized customer service and an extensive product line allows us to serve the needs of hospitals, surgical centers and more throughout the US and internationally. This position is based in Eden Prairie, MN; relocation is not available for this role.

Job Type: Full-time

Benefits:

  • 401(k)
  • 401(k) Matching
  • Dental Insurance
  • Disability Insurance
  • Employee Assistance Program
  • Flexible Spending Account
  • Health Insurance
  • Life Insurance
  • Paid Time Off
  • Parental Leave
  • Referral Program
  • Vision Insurance

Schedule:

  • Monday to Friday

Experience:

  • Quality Systems Management: 5 years (Required)
  • Medical Industry: 5 years (Required)

Education:

  • Bachelor's (Required)

Work authorization:

  • United States (Required)

Additional Compensation:

  • Bonuses

Company's website:

  • www.keysurgical.com

Company's Facebook page:

  • https://www.facebook.com/keysurgical

Benefit Conditions:

  • Waiting period may apply
  • Only full-time employees eligible

Work Remotely:

  • Temporarily due to COVID-19

Please mention that you come from RemoteJobs when applying for this job.

Posted 1 week ago

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