rms Surgical
  • 11-Jan-2018 to 12-Mar-2018 (EST)
  • Quality
  • Anoka, MN, USA
  • Salary
  • Full Time

Medical, Dental, Vision, 401k, Profit Sharing, Short-Term Disability, Life Insurance, PTO

A 100-year tradition of quality

Cretex is a diversified family of manufacturing companies serving the medical market. Our companies share a common set of values, a common management system, and a pervasive focus on quality, customer service and responsiveness. We've been around for 100 years and by doing the right things well, we plan to be around for many more.

Upholding a true standard for ethical excellence

For nearly a century, Cretex has earned a reputation for consistently holding true to the core principles of honesty and integrity. Our employees take great pride in their work and the level of service they offer our customers. Because of this, our companies continue to earn the highest level of confidence and loyalty from our customers, suppliers, employees, owners and stakeholders.

Bringing the best together through technology and talent.

The Cretex Medical family of companies provide a broad range of contract manufacturing solutions to medical device OEMs. Our private ownership, long-term perspective and strong financial portfolio allow us to invest in the leading-edge manufacturing technologies and engineering resources required to meet the most exacting requirements of the medical device industry. Our growing portfolio of companies include rms, rms Surgical, Meier, JunoPacific, Spectralytics and QTS; providing manufacturing capabilities that include precision machining, plastic injection molding, micro stamping, metal forming, laser micromachining, surgical instruments and clean room assembly and packaging.

rms Surgical, a Cretex Medical Company, emerged from rms and JunoPacific, leading medical device manufacturing companies with a worldwide reputation for providing precision machined implants and other devices to the medical device industry. 

rms Surgical is a single-source provider of custom instrumentation and sterilization cases and trays for the medical device market. Complete design capability complements the sterilization case and tray manufacturing with an emphasis on fast turnaround of prototype and production requirements. The instrumentation manufacturing is supported by dedicated prototype capability and design for manufacturability support. Join our dedicated team of professionals!

Position summary

The Sr. Quality Systems Specialist will be responsible for developing, implementing and maintaining the quality management systems. 

Essential Job Functions                                                                

  • Lead in second and third party audits, including audit preparation, execution, reporting and follow-up activities
  • Manage the internal audit program from the selection and training of the internal audit group through the implementation of effective corrective actions. The audit program is responsible for maintaining and improving a quality system which meets the requirements ISO 13485, and FDA QSR
  • Perform process and product audits to identify gaps and deficiencies and implement process improvement initiatives utilizing lean techniques
  • Provide leadership in Company regulatory matters and support customers regarding their regulatory needs
  • Develop and maintain a Global Quality System model that scales with organizational growth
  • Represent Quality on the Supplier Qualification Team. Co-chair the supplier performance meetings and ensure program requirements are up-to-date, including the Approved Supplier List. Lead/coordinate Supplier audits  
  • Identify, develop, and maintain relevant QMS training programs to promote quality awareness and ensure compliance to company policies and procedures
  • Partner with quality and operations to implement quality system improvements
  • Implement, maintain, and provide issue resolution in regards to the Global Quality System software (ZenQMS)

Minimum Requirements, Education & Experience (incl. KSA's and certifications)

  • Five (5) years of experience managing quality management systems
  • Experience with ISO 13485:2016 and FDA
  • Bachelor's degree or equivalent work experience of six (6) years
  • 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 customer's requirements
  • Focus on Operational Excellence
  • Project management skills
  • Good attention to detail
  • Good communication skills
  • Strong problem solving skills
  • Ability to work in a manufacturing environment
  • Ability to use Microsoft Office (Word/Excel/PowerPoint) and ERP and other business related systems

Desirable Criteria & Qualifications

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

Physical & Environmental Demands

  • Ability to work in a manufacturing environment

Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, 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 www.dhs.gov/E-Verify

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