Quality Systems Manager

Quality Systems ManagerQTS offers critical end-of-line services for medical device OEMs including finished device assembly, packaging and sterilization management. QTS is part of the Cretex Medical family of companies.ResponsibilitiesQTS is currently seeking an energetic, responsive and well-organized full time Quality Systems Manager. This position will be responsible for developing, implementing, and maintaining the quality management system. Additionally, the Quality Systems Manager will manage Document Control and CAPA facilitators.Quality Systems Manager Job Summary:Take the 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.Responsible for maintaining and improving a quality system which meets the requirements ISO 13485, and FDA QSR.Manage CAPA facilitators in customer complaints, and internal CAPA process using failure analysis, development of corrective and preventative actions and trend analysis.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.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 regarding the Global Quality System software (ZenQMS).Assist in preparation of management review data and presentation.Lead, coach, and mentor the QMS team.QualificationsQuality Systems Manager Skills and Experience:Bachelor's 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 customer's requirements.Project management skills.Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher).Clear and effective verbal and written communication skills.High attention to detail and great organizational skills.Ability to work in a fast-paced team environment.Desirable Criteria & Qualifications:Quality systems experience in a manufacturing setting.Continuing education; including participation in local chapters, associations, and/or organizations.What Is It Like to Work for QTS?At QTS, we are passionate about quality as the services we provide have a direct impact on the quality of life for others and we pride ourselves on our culture and work environment. Here are some of things that employees have said about working at QTS:"I would describe my coworkers as kind and friendly.""… I interned at QTS, then I went back to school… I was brought on as a shared service engineer, then I moved into a role with more customer interaction associated with it. All in all, a good, fun ride so far and I can't wait to keep it going!""Three words that I would use to describe QTS's culture are: Respectful, Fast-paced, and Fun!"We encourage you to explore the many opportunities that Quality Tech Services could offer you as an employee and as a valued team member.Pay RangeUSD $97,000.00 - USD $123,000.00 /Yr.Company BenefitsAll 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.20+hours:Cretex's 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.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 Cretex QTS