Director, Quality and Compliance

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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About MedTech

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at are searching for the best talent for a Director Quality and Compliance to be located at Plymouth MN.

The Director of Quality & Compliance establishes policy to ensure compliance with respect to domestic and international regulations. Also plans coordinates and directs product development and manufacturing quality programs designed to ensure products are consistent with established standards by performing the following duties personally or through subordinates.

The Director serves as Management Representative with executive authority for quality systems for a business of small to medium size and complexity. The Director is an essential team member on the Sterilmed Board and the New Product Development Committee to contribute to overall business strategy and direction.

You will be responsible for:

• Plans and directs resources and activities of the quality functions.

• Responsible for ensuring that new products are developed in accordance to Design Control procedures and standards.

• 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 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.

• Partner with Regulatory Affairs to analyze and anticipate changes to the regulatory environment that may impact Sterilmed stakeholders (i.e. patients physicians payers providers)

• Collaborate 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

• Influence and implement company policies and strategic direction in regulatory compliance based on current and emerging regulatory trends

• Effectively negotiate and influence 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 products conform to established company and regulatory standards

• Advises staff to help meet established schedules or resolve technical or operational problems

• Formulates and maintains quality objectives and coordinates objectives with pre-production and production procedures in cooperation with other manufacturing managers to maximize product reliability and minimize costs

• Acts in the capacity of designated Official Correspondent with the Food and Drug Administration Notified Body and foreign governments for regulatory compliance inspections and State of Minnesota in matters of establishment registrations and related matters

• Responsible for ensuring 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.

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

Qualifications / Requirements:

Education:

• A minimum of a Bachelors degree in Science Biomedical or Engineering discipline is required. Masters degree in physical or biological sciences preferred.

• Advanced ASQ certifications such as CQM CQE CQA or CRE preferred.

Experience and skills:

• At least 10 years quality systems experience in medical device

• Minimum of 5 years management experience

• Prior experience in the medical device industry is required

• Project Management experience preferred

• Comprehensive expertise in U.S. government regulations regarding registration and market introduction of medical devices preferable

• Knowledge of regulatory affairs processes applicable regulations and product filings/submissions preferable

• Experience working with regulatory authorities and certification bodies.

• Strong Statistical skills (i.e. frequency distributions reliability and validity of tests normal curve analysis of variance correlation techniques sampling theory or factor analysis)

• Knowledge of and compliance with applicable Quality System requirements (e.g. QSRs ISO and MDD requirements)

• Strong written and verbal communication skills to communicate effectively at all levels Strong problem-solving skills time management and communication skills

• Practical knowledge of QSR ISO and GLP regulations

• In-depth knowledge of quality and manufacturing systems and processes and applicable regulations i.e. ISO 13485 FDAs GMP and QSR requirements for medical devices. Superior regulatory technical and business knowledge to develop operational strategies for continued quality assurance.

• Demonstrated analytical and problem-solving skills. Excellent understanding and demonstrated use of PE/Six Sigma tools and methodologies.

• Ability to work in a global fast paced environment and rapidly shifting priorities

• Working knowledge and experience in managing third party inspections and negotiating with 3rd parties on compliance issues.

• Well-developed Influencing and negotiation skills. Ability to effectively train and mentor a diverse array of employees at all levels of the organization.

• This position may require up to 10% of domestic and/or international travel.

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 & 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 external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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Director