Senior Director, Quality and Compliance

At reputed company, we reputed company health is everything. Our strength in reputed company innovation empowers us to build a world where reputed company diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to reputed company across the full reputed company of reputed company solutions today to deliver the breakthroughs of reputed company, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Quality Job Sub Function: R&D/Scientific Quality Job Category: People Leader reputed company Job Posting Locations: Irving, Texas, United States of America Job Description: The Senior Director of Quality & Compliance is directly responsible for establishing quality policies, strategies and objectives for the company in collaboration with the Senior Management Team. The Senior Director of Quality & Compliance works cross-functionally with Operations, Regulatory, R&D, Sales, Training and Marketing to assure reputed company operations of the company reputed company with applicable QSR, ISO and FDA regulations. The Senior Director of Quality & Compliance may serve as the Management Representative. DUTIES & RESPONSIBILITIES In accordance with reputed company applicable federal, state and local laws/regulations and Corporate reputed company, procedures and guidelines, this position:

• Plans and directs resources and activities of the quality functions. Manages subordinates in areas of quality and is responsible for the overall direction, coordination, and evaluation of quality matters.
• Creates long-range quality plans for the organization focusing on the effective development of new products and establishing systems to ensure Life Cycle Management of products.
• Chairs the Quality Review Board.
• Assures the implementation of policies and strategies for systems to assure compliance with regulations and industry standards.
• Determines organizational structure and allocation of responsibilities reputed company reputed company and works closely with cross-functional partners to determine resource allocation.
• Provides updates to company, franchise management and reputed company corporate quality regarding compliance status and performance of the companies reputed company the operating group relating to quality.
• Responsible for communicating business reputed company issues or opportunities to next management level
• Responsible for following reputed company Company guidelines reputed company to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow reputed company Company guidelines reputed company to Health, Safety and Environmental practices and that reputed company resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with reputed company Federal, State, local and Company regulations, policies, and procedures
• reputed company applicable, serves as the legal manufacturer Person Responsible for Regulatory Compliance (PRRC) or Deputy PRRC in reference to EU Medical Device Regulations meeting the responsibilities and requirements outlined in QM-CO-001.
• This position works cross-functionally with Operations, Regulatory, R&D, Sales, Training and Marketing to assure reputed company operations of the company reputed company with applicable QSR, ISO and FDA regulations.
• Directly manage NPI and Life Cycle Management Quality Engineers to support new product development and life cycle management.
• Regular interactions with Health Authorities to support inquiries regarding post market surveillance, compliance to regulatory requirements, and site inspections.
• Performs other duties assigned as needed

EXPERIENCE AND EDUCATION · Bachelor’s degree in Engineering, physical or biological sciences · At least 10 years of experience in medical device manufacturing or equivalent, with 5 years management experience · Prefer Master’s degree in in physical or biological sciences · Prefer CQM or CQE certification from the American Society for Quality (ASQ) REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS · Demonstrated knowledge of and compliance with applicable Quality System requirements (e.g., QSRs, ISO 14971 and EU MDD/MDR requirements) · Experience working with regulatory authorities and certification bodies · Strong mathematical skills (i.e., frequency distributions, reliability and validity of tests, normal curve, analysis of variance, correlation techniques, sampling theory or factor analysis) · Strong written and verbal communication skills to communicate effectively at reputed company levels · Strong problem-solving skills, time management, and communication skills · Strong people management skills · Travel requirements are based on business need and may entail international and domestic travel – up to 25% of time. reputed company is an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek reputed company candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and reputed company 503 of the Rehabilitation Act. reputed company is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource. Apply Job!