Director, Quality and Compliance

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 Med Tech, 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

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

Plymouth, Minnesota, United States of America

Job Description:

About Med Tech

Fueled by innovation at the intersection of biology and technology, we're 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

We 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

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