Quality Systems Manager

Quality Systems Manager Position Summary The Quality Systems Manager is responsible for the 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 governance, timely execution, 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. Responsibilities Audit Leadership & Regulatory Readiness – Provide leadership oversight to second- and third-party audits, including preparation, execution, reporting, and closure of audit findings. Internal Audit Program Management – Lead the internal audit program, including auditor selection, training, audit scheduling, execution, and driving timely and effective corrective actions. QMS Compliance & Continuous Improvement – Develop, maintain, and continuously improve a robust QMS compliant with ISO 13485, FDA 21 CFR Part 820, and applicable global regulations. 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 to identify gaps 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. Global QMS Strategy & Standardization – Establish and maintain a global QMS framework that supports multi‑site operations, harmonization, and future growth. Supplier Quality Integration – Represent Quality on the Supplier Qualification Team and supplier performance reviews. Training & Quality Culture Development – Develop and sustain QMS training programs to drive compliance, enhance quality awareness, and build a culture of accountability. 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 – Implement, maintain, and optimize Global QMS software, ensuring system effectiveness, data integrity, and user adoption. Management Review & Metrics Support – Provide preparation and presentation of Management Review inputs. Team Leadership & Development – Lead, coach, and mentor the QMS team, fostering a high‑performing organization. Qualifications Requirements 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 regulatory requirements. Lead Auditor Certification. Ability to consistently achieve short and long‑term business results. Ability to prioritize work and manage multiple tasks. 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. Attention to detail. Organizational skills. Ability to work in a fast‑paced team environment. Ability to prioritize and multitask. Preferred Requirements Quality systems experience in a manufacturing setting. Continuing education; participation in local chapters, associations, and/or organizations. Pay Range USD $100,900.00–USD $151,300.00/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. 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. Company Benefits This is a bonus eligible position. All employees: 401(k) retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program, Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program, employee death benefit, and employee sick and safe leave. Working 20+ hours/week: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners covers services 100 % for children 12 and younger when seen by an in‑network provider); vision insurance; pre‑tax health savings account, healthcare and dependent care pre‑tax reimbursement accounts; paid holidays, paid time off; and discretionary profit sharing. Working 30+ hours/week: parental leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long‑term disability; company‑provided life insurance; tuition assistance programs. EEO Statement 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. Additional Information 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 #J-18808-Ljbffr