Join VitalPath in Cokato as a Quality Manager!

About VitalPath:

VitalPath is a trusted partner in the catheter design and manufacturing of custom medical devices that save lives and restore patient health and vital function. We’re excited about this important work and bring vital energy to our customer partnerships. In our growing organization it’s important that we continue to offer a small-company, family-oriented environment with competitive pay and benefits. If you want to make a difference in people’s lives and be a part of a friendly, fun place to work with people that value diversity, come join our team!

About the Position:

The Quality Manager manages the Quality department provides overall leadership of the site’s quality efforts and oversees all aspects of the Quality System. The Quality Manager ensures repeatable and measurable processes are in place to consistently meet customer expectations and specifications and comply with ISO 13485 and FDA requirements. This person will also ensure systems are in place to measure processes, monitor performance and hold team members accountable. As part of the site leadership team the Quality Manager will work in cross functional teams to establish and execute quality improvement strategies based on customer requirements utilizing advanced quality tools to elevate quality performance.

Job Duties

• Lead the quality department and develop a team of passionate, proactive, knowledgeable, and collaborative individuals who provide fact-based feedback and monitoring of the company’s Quality system as well as collaborate and partner to improve effectiveness and efficiency
• Plan, schedule, and manage product quality control activities to ensure production is consistent with established standards and customer specifications
• Establish and monitor Key Performance Indicators for trends and improve metrics related to yield, nonconforming product, CAPA, audits and customer complaints
• Serve as the ISO 13485:2016 Management Representative
• Ensure that processes needed for the Quality Management System (QMS) are established, implemented, and maintained.
• Ensure that the performance of the QMS is reviewed at planned intervals to ensure its continuing suitability, adequacy, and effectiveness. This review means assessing opportunities for improvement and the need for changes to the QMS.
• Ensure that records are established and maintained to provide evidence that the QMS is being followed and that there is a system in place for the identification, storage, protection, retrieval, retention time and disposition of such records
• Manage and maintain all aspects of the quality system to support the design, development, manufacturing, and distribution of medical devices/products
• Identify and prioritize complaints and handle CAPA systems, ensuring investigations, root cause determination, implementation, and effectiveness checks are adequately addressed and documented in a timely manner
• Communicates objectives, impacts and expectations of quality improvement action plans to management team, task force and production team
• Maintain risk management files for all new and existing devices
• Ensure training to internal QMS and appropriate external standards is being completed
• Lead cross functional teams in planning and conducting analyses (hazard identification, hazard analysis, failure mode effects and analysis, etc.) and mitigations
• Ensure that a document control procedure is adopted to approve, review and update changes to critical documents within the scope of the QMS

Minimum Skills & Experience Required

• Bachelor of Science or Arts (BS/BA) In Business, Management, or similar.
• 7 years in progressive quality leadership roles including leader of people.
• Minimum of 5 years of experience assessing, improving, and building quality processes to comply with ISO 13485:2016 and FDA compliance
• Strong leadership – influence and coach across all levels of the organization
• Experience in multiple areas of Quality including Inspection, Complaints, Managing CAPA, MRB
• A bachelor’s degree in engineering or related discipline and 3-5 years managing a quality system
• Experience with accrediting and maintaining ISO13485:2016 or related ISO standard
• Ability to participate in telephone conferences and sit in meetings for up to 2 hours continuously
• Communication skills – proactively set expectations and accountabilities
• Process oriented – high expectations of getting results through self and team
• Problem solver – clearly defines a problem and finds areas of opportunity within it
• Analytical mindset - involves a methodical step-by-step approach to thinking break down complex problems into single, manageable, and reportable components
• Limited travel required. Mainly from Cokato site to other VitalPath Locations around MN

Preferred Skills & Experience

• Certification as Auditor / Lead Auditor
• 3-5 years of experience influencing and leading cross functional teams on quality standards
• 5-7 years in Manufacturing Engineering or Quality Engineering experience in medical device industry
• 5-7 years of experience assessing, improving, and building quality processes to comply with ISO 13485:2016 and FDA compliance
• Experience working in a multi-projects and lean manufacturing environment
• Experience in Software Validation
• Experience in Risk Management processes and methodology

Benefits of working at VitalPath:

• Comprehensive, Low Cost Health and Dental Insurance Plans Available
• Vision Insurance
• Health Savings Account with company contribution
• Short and Long Term Disability
• Supplemental insurances (short term disability, AD&D, life insurance, and more)
• Paid Time Off
• Paid Holidays
• 401K with company match
• Competitive compensation
• Opportunities for career growth and advancement

VitalPath is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, work related mental or physical disability, veteran status, sexual orientation, gender identity, or genetic information. VitalPath participates in E-Verify.

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