We Hire America Jobs

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex 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 innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, 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

All 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 all operations of the company comply with applicable QSR, ISO and FDA regulations. The Senior Director of Quality & Compliance may serve as the Management Representative.

DUTIES & RESPONSIBILITIES

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, 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 within the Quality group and works closely with cross-functional partners to determine resource allocation.

• Provides updates to company, franchise management and Johnson & Johnson corporate quality regarding compliance status and performance of the companies within the operating group relating to quality.

• Responsible for communicating business related issues or opportunities to next management level

• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

• When 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 all operations of the company comply 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 all 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.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson 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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.