Director - Design Quality Assurance - Tissue Technologies

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. SUMMARY The Director, Design Quality Assurance (DQA) – Tissue Technologies division is responsible for ensuring the delivery of high‑quality design history files (DHF) and Risk management files (RMF) that comply with applicable global regulations. The role oversees design controls focused on risk management, compliance, quality, customer requirements, and manufacturability, and manages quality programs and policies for the development, manufacture, and distribution of medical devices in accordance with corporate policies and U.S. FDA, ISO 13485, CMDR, EU MDR, and JPAL. ESSENTIAL DUTIES AND RESPONSIBILITIES Directly supervise employees in the quality assurance organization, including recruiting, hiring, training, performance appraisal, and disciplinary actions. Build high‑performance cultures and teams, encouraging accountability for successful implementation of quality assurance initiatives and continuous improvement. Provide strategic direction and communicate the company’s goals, directives, and policies to subordinates, fostering a clear vision and collaborative environment. Drive design control standardization for the division, ensuring DHF files comply with regulations, and lead remediation to meet launch timelines. Oversee product quality reviews, divisional management reviews, and preparation of quality reports for various forums. Direct activities of the Quality Department to ensure compliance with all relevant regulations and standards. Coordinate with other departments, external vendors, and customers, influencing process improvements and opportunity identification. Perform other related duties as assigned. DESIRED MINIMUM QUALIFICATIONS Bachelor’s degree with a minimum of 15 years’ experience, including at least 10 years of people‑management or program‑leadership experience; master’s degree preferred. Experience in medical device design and manufacturing. Strong analytical, writing, and interpersonal skills. Significant expertise and a positive track record in relevant areas. Demonstrated knowledge of FDA regulations, ISO 13485, CMDR, EU MDR, JPAL, and other international standards. Experience with direct contact with FDA and EU Notified Bodies. Knowledge of process design, change control, auditing, and document management systems. Excellent organizational, management, and communication skills. Proficiency in reading and writing English, demonstrated by successful completion of written tests. Ability to travel up to 25% or more as needed. Salary Salary Pay Range: $166,750.00 – $228,850.00 USD. Individual pay is determined by factors such as job‑related skills, experience, and education. Eligible employees may receive bonus, commission, equity, or other variable compensation. Your recruiter can share more specific salary details for your preferred location during the hiring process. Benefits Employees and eligible dependents are eligible to participate in company‑sponsored benefits programs including medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, group legal insurance, and a 401(k) savings plan. Equal Opportunity Statement Integra LifeSciences is an equal opportunity employer and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you’d like more information on your rights under the law, see “EEO Is the Law” and “EOE including Disability/Protected Veterans.” Integra LifeSciences is committed to providing qualified applicants and employees who are disabled veterans or have disabilities with reasonable accommodations under the ADA. If you need an accommodation, email careers@integralife.com. Agency Submission Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. CVs/resumes submitted by search firms without a valid written search agreement will be considered the sole property of our company, and no fee will be paid if a candidate is hired without a pre‑existing agreement. Intregrta - Employer Branding from Integra LifeSciences on Vimeo. #J-18808-Ljbffr