Quality Systems Manager

About Cretex Medical:

Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding laser processing metal stamping and device assembly. Learn more at .

Quality Systems Manager Position Summary:

TheQuality Systems Manageris responsible forthe development implementation maintenance and continuous improvement of the Quality Management System (QMS) in compliance with applicable regulatory requirements (e.g. FDA 21 CFR Part 820 ISO 13485 and other global standards).Key responsibilities include managing Document Control and CAPA functions ensuring robust governancetimelyexecution and effectiveness of quality system processes. The role partners cross-functionally with Operations Engineering and Supply Chain to embed quality into all stages of the product lifecycle and to support audit readiness and inspection success.

• Audit Leadership & Regulatory Readiness
  Lead second- and third-party audits including preparation execution reporting and closureof audit findings. Ensure sustainedinspection ofreadiness and successful outcomes with regulatory bodies and customers.

• Internal Audit Program Management
  Own the internal audit program including auditorselection training audit scheduling execution and drivingtimelyand effective corrective actions to strengthen the QMS.

• QMS Compliance & Continuous Improvement
  Developmaintain and continuously improve a robust Quality Management System compliant with ISO 13485 FDA 21 CFR Part 820 and applicable global regulations ensuring scalability with organizational growth.

• CAPA & Complaint Management Oversight
  Lead CAPA facilitators and ensure effective management of customer complaints and internal CAPAs including root cause analysis corrective/preventive actions effectiveness checks and trend analysis.

• Process & Product Quality Improvement
  Conduct process and product audits toidentifygaps and drive continuous improvement initiatives using Lean and risk-based methodologies.

• Regulatory & Customer Interface
  Provide leadership in regulatory matters and serve as a key quality representative to customers ensuring alignment with regulatory requirements and customer expectations.

• Global QMS Strategy & Standardization
  Establish and maintain a global QMS framework that supports multi-site operations harmonization and future growth including acquisitions and integration efforts.

• Supplier Quality Integration
  Represent Quality on the Supplier Qualification Team co-chair supplier performance reviewsmaintainthe Approved Supplier List (ASL) and lead supplier audits to ensure supplier compliance and performance.

• Training & Quality Culture Development
  Develop and sustain QMS training programs to drive compliance enhance quality awareness and build a culture of accountability and continuous improvement.

• Cross-Functional Collaboration
  Partner with Quality Operations Engineering and other functions to implement QMS improvements that enhance efficiency compliance and product quality.

• Digital QMS Systems Management
  Implementmaintain andoptimizeGlobal QMS software ensuring system effectiveness data integrity and user adoption.

• Management Review & Metrics
  Support preparation and presentation of Management Review inputs ensuring clear visibility to QMS performance risks and improvement opportunities.

• Team Leadership & Development
  Lead coach andmentor tothe QMS team fostering a high-performing organization with strong accountability engagement and capability development.

Quality Systems Manager Requirements:

• Bachelors degree or 6 years of equivalent work experience
• 5 years of experience managing quality management systems
• Experience with ISO 13485:2016 and FDA
• Lead Auditor Certification
• Ability to consistently achieve short and long-term business results
• Ability to prioritize work and manage multiple tasks when needed
• Ability to follow through on commitments and hold team members accountable
• Consistently produces work that meets the customers requirements
• Project management skills
• Microsoft Office proficiency (Outlook Word Excel PowerPoint Publisher)
• Clear and effective verbal and written communication skills
• Attention to detail
• Organizational skills
• Ability to work in a fast-paced team environment
• Ability to prioritize and multitask

Quality Systems Manager Preferred Requirements:

• Quality systems experience in a manufacturing setting
• Continuing education; including participation in local chapters associations and/or organizations

What is it like to work at Cretex Medical

We recognize the contribution of every individual and promote growth safety and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement.

Here are some of things that employees have said about working for Cretex Medical:

• The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director a machinist or your boss. Everyone is always willing to help you figure out a project and get it done right.
• I would tell potential interns that Cretex is a great company to work for. It has set a high bar for corporate culture as well as the quality of work you can do. I would definitely recommend it.
• I learned that I really like the medical device industry. The importance and the gravity of what we do here is felt by the employees. You can have that passion in your work because you know what you are striving for is to save lives.

We encourage you to explore the many opportunities Cretex Medical can offer you as a valued team member.

This pay range reflects the base hourly rate or annual salary for positions within this job grade based on our market-based pay structures. Actual compensation will depend on factors such as skills relevant experience education internal equity business needs and local market conditions. While the full hiring range is shared for transparency offers are rarely made at the minimum or maximum of the range.

Compensation:

This is a bonus eligible postion.

All Employees:

Our 401k retirement savings plan with a company match contribution; onsite health clinics discretionary holiday bonus program (based on years of service) Cretex University 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost wellness program with incentives an employee death benefit and employee sick and safe leave are available to all Cretex employees.

20hours:

Cretexs medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre-tax health savings account healthcare and dependent care pre-tax reimbursement accounts; paid holidays paid time off; and our discretionary profit sharing program are available to employees working 20 hours/week.

30 hours:

Parental Leave accident and critical illness benefits optional employee spouse and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30 hours per week.

(Some benefits are subject to eligibility criteria.)

Applicants will receive consideration for employment regardless of their race color creed religion national origin sex sexual orientation gender identity disability age veteran status marital status family status status with regard to public assistance or any other protected status as required by law.

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 visit Experience:

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