Quality Manager

Quality Manager Job Locations US-MN-Bloomington

ID 2026-5926

Category Quality Position Type Regular Full-Time Overview About QTS QTS 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 ofpanies. Learn more at qtspackaging and cretexmedical. Responsibilities Quality Manager Ideal Candidate Profile QTS is currently seeking an experienced, energetic, responsive, and wellanized full time Quality Manager. This position will be responsible for building, managing, and leading the quality department staff, working in partnership with sales, engineering, procurement, and operations, to ensure the highest possible quality products to the QTS Quality Management System. This role will support our customer facing function to ensure customer requirements are met, drive quality customermunications, and support the quality and delivery of the products. This position will ensure the products and processes meet the quality management system requirements and methods in alignment with the FDA QSR and ISO requirements and utilize metrics to continually improve quality processes and efficiency. This would be an on-site position. •This position is not currently offering relocation assistance. Quality Manager Job Summary Establish and lead a high-performing team of Quality Engineers, Quality Technicians, and Customer Facing Quality, providing mentorship and coaching to staff as needed. Manage customer qualitymunication and relationships. Assist in the resolution, documentation, customer responses forplaints. Execute quality policies, quality objectives, and quality plans that support the corporate strategic business goals and conform to customer, internal, ISO 9001:2015 and

EN ISO 13485

2016, regulatory and legal requirements. Ensure effective coordination of investigations, root cause analysis, risk assessments, field actions and implementation of change control and corrective and preventive actions to the add timelines. Professional and timely cross functionalmunication with other departments and customers. Monitor and assess the QMS processes forpliance, effectiveness, and opportunities for improvement, ensuring product meets requirements and continued certification to applicable standards. Maintain Quality System Dashboards, Scorecards / Key Performance Indicators for the quality of products. Review and monitor trends,municating issues to department management. Contribute to and assist in providing quality system training as appropriate. Assures in process inspection, batch record review, sterile and product releaseplies with the quality system. Support the Management Review process. Drive process implementation including quality control plans, validation, qualifications (IQ, OQ, PQ) and root cause - corrective action. Support a culture of Operational Excellence, inclusive of lean and six sigma principles. Act as the Deputy Management Representative should need arise. Act as a representative for customer audits, and support external audits by regulatory authorities and registration agencies. Qualifications Quality Manager Skills and Experience Bachelor's degree in Engineering, Sciences, Quality, or relevant experience. 8 years of experience in Quality or Engineering in a manufacturing setting in a regulated field. 5 years of leadership experience. Clear and effective verbal and writtenmunication skills. Strong attention to detail andanizational skills. In depth knowledge of 13485, 14971, FDA Quality System Regulation, 21CFR Part 820, Good Manufacturing Practices, or other relevant regulated requirements. Experience with Corrective and Preventative Actions, including the ability to lead cross functional teams to solve problems andplete root cause analysis. Working knowledge of quality tools, variable and attribute sampling plans, root cause analysis, DOE, Statistics, Lean Manufacturing, and Six Sigma - an asset. Demonstrated leadership skills with the ability to build, mentor and maintain an efficient, effectiveanization with a team focused on continual improvement and holds team members accountable. Experience with finished device manufacturing. Ability to prioritize, plan, and evaluate deliverables to established strategic goals and timeline. Ability to consistently achieve short and long-term business results. Ability to work in a fast-paced team environment. Desirable Criteria & Qualifications Continuing education, including participation in local chapters, associations, and/oranizations. 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 d 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 Range USD $97,900.00 - USD $146,900.00 /Yr. Pay Range Details This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market-based pay structures. Actualpensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is d for transparency, offers are rarely made at the minimum or maximum of the range. Company Benefits

All Employees:

Our 401k retirement savings plan with apany 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:prehensive 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;pany 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.