Director, Quality and Compliance

Johnson & Johnson Innovative Medicine•Plymouth, MN

2d•Onsite

About The Position

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/medtech 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.

Requirements

A minimum of a Bachelor’s degree in Science, Biomedical or Engineering discipline is required.
At least 10 years’ quality systems experience in medical device
Minimum of 5 year’s management experience
Prior experience in the medical device industry is required
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, FDA’s 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.

Nice To Haves

Master’s degree in physical or biological sciences preferred.
Advanced ASQ certifications such as CQM, CQE, CQA or CRE preferred.
Project Management experience preferred

Responsibilities

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.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the 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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits