Director, Quality and Compliance

Director, Quality and Compliance

Johnson & Johnson Med Tech seeks a director to establish policy and lead quality and compliance programs in Plymouth, MN.

Plymouth, Minnesota, United States

Quality Assurance

Full-time

$ - $

Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible for the Company’s long‑term incentive program.

• Vacation – 120 hours per calendar year
• Sick time – 40 hours per calendar year (48 hrs in Colorado, 56 hrs in Washington)
• Holiday pay – 13 days per calendar year (incl. floating holidays)
• Work, Personal and Family Time – up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52‑week rolling period (10 days)
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time‑Off – 80 hours per calendar year

• Plans and directs resources and activities of the quality functions.
• Ensures new products are developed in accordance to Design Control procedures and standards.
• Creates long‑range quality plans for the organization focusing on effective development of new products and establishing systems to ensure Life Cycle Management of products and manufacturing controls.
• Assures the implementation of policies and strategies for systems to assure compliance with regulations and industry standards. Implements an integrated quality management system approach balancing customer satisfaction and regulatory compliance with business objectives.
• Attends Risk Management Board and Quality Review Board meetings to provide product quality expertise and may lead failure investigation discussion for issues related to product design or manufacturing.
• Identifies opportunities to continuously improve quality, cost and time factors, consistent with business objectives.
• Influences the various business strategies by ensuring an appropriate balance of business, customer and regulatory requirements and emerging trends.
• Develop and sets strategic direction for quality and that integrates customer, product and market requirements in design controls and manufacturing process controls.
• Formal designee as the Management Representative of the Quality System. Responsible for ensuring management reviews of the quality system are conducted effectively.
• Maintains up‑to‑date knowledge of global medical device regulations and standards affecting product development.
• Partners with Regulatory Affairs to analyze and anticipate changes to the regulatory environment that may impact Sterilmed stakeholders (i.e., patients, physicians, payers, providers).
• Collaborates with Quality, Compliance, Regulatory Affairs, Legal, Reimbursement and other partners to develop and implement processes that address new/revised legislation relevant to Sterilmed business plans.
• Influences and implements company policies and strategic direction in regulatory compliance based on current and emerging regulatory trends.
• Effectively negotiates and influences upper management, regulatory agencies and industry to ensure compliance with regulatory and business needs.
• Provides updates to company, franchise management and Johnson & Johnson corporate quality regarding compliance status and performance of the company.
• Proactively and effectively evaluates, manages and communicates risk.
• Manages subordinates in areas of quality and is responsible for the overall direction, coordination and evaluation of quality matters.
• Provides consultation to all functional management groups by providing compliance input for new projects, including but not limited to, product development, manufacturing and distribution.
• Directs implementation of new Quality & Compliance programs required by regulations or Johnson & Johnson directives.
• Establishes and maintains quality programs, procedures and controls between core teams, especially in development and manufacturing activities. Ensures that performance and quality of…