SENIOR QUALITY ENGINEERING MANAGER

Johnson & Johnson Sterilmed Inc, a member of the Johnson & Johnson Family of Companies is currently recruiting for a Senior Quality Engineering Manager ! This position will be located in Plymouth, MN.
The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century.
With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide.
Together, we are working to shape the future of health through differentiated products and services.
Position Summary.
The Quality Manager will work to continuously improve Sterilmed’s Quality Systems while maintaining compliance to ISO and FDA requirements.
Establishes and maintains quality assurance programs, procedures, and controls.
Ensures that performance and quality of products conform to established company and regulatory standards.
Manages investigation of validation problems and conducts qualification activities.
Develops and implements policies and procedures.
Manages documentation for new and current validation and /or qualification procedures and technical reports.
Key Responsibilities.
· Plans, coordinates, and directs quality assurance programs designed to ensure continuous production of products consistent with established standards by performing the following duties personally or through subordinates.
· Assures all products conform to existing quality requirements, standard operating procedures, and government regulations and adheres to all good manufacturing practices.
· Participates in quality investigations and/or internal audits to assess conformance to specifications, company procedures, and overall compliance to regulations.
· May approve complaint handling investigations.
· May evaluates and analyzes statistical and data analysis for projects involving the design, development or validation of new or existing products and processes.
· Responsible for the overall management and effectiveness of the corrective action and preventive action (CAPA) and risk management processes · Acts as advisor to subordinate supervisors or staff to help meet established schedules or resolve technical or operational problems.
· May determines design direction or product line modifications and adequacy of design and test results.
· Oversees the development and implementation of processes, procedures, audits and corrective actions.
· Ensures effective communication and training are deployed throughout the business.
· Participate in planning and implementing changes in production methods, tooling and equipment, space allocations, workforce utilization, production schedules, lines and other factors required to maintain or improve compliance with quality standards of existing products and to establish initial and.
Develops and implements systematic and effective processes to investigate and resolve customer complaints and problems.
· Manages the development and implementation of metrics and systems to measure and guide improvements to product and system quality and customer satisfaction.
· Requests data and metrics reports obtained from quality databases and files for inclusion in management reports.
· Examines results from management reviews, third party inspections and internal audits and approves proposed corrective actions.
· Participates as Subject Matter Expert for internal and external audits.
· Mentors, coaches, trains and develops the quality control staff.
Evaluates performance and provides opportunities for growth.
Communicates department objectives and metrics and measures results.
· Supports product release activities.
· Oversees the Quality Department.
· Responsible for communicating business related issues or opportunities to next management level.
· 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.
· Performs other duties assigned as needed.
· Manages daily operation of validation department.
· Designs and develop validation and qualification policies, procedures, programs related to facilities, processes (including cleaning, methods...), equipment and automated systems.
· Manages the validation approach and strategy to ensure continuous improvement consistent with established and evolving regulatory and company requirements.
· Maintains up to date knowledge of the industry and regulatory trends related to all aspects of validation as well as knowledge on company product.
· Serves as the validation expert on the team and provide validation oversight and guidance.
· Responsible for communicating and elevating critical business-related issues as well as opportunities to senior management.
· Manages companywide validation programs and provides guidance and expertise to project teams for all validations.
· Plans, promotes and organizes required training activities related to different validation areas.
· Participates in establishing key performance metrics to evaluate validation efficiency.
· Establishes operational budget.
· Monitors departmental validation activities to ensure that subordinates follow all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are.
· Establishes and ensures the rigor of testing performed during all qualification/validation activities to be consistent with regulatory requirements and industry standards.
Qualifications Education.
A minimum of a Bachelor’s or equivalent University degree is required.
Required.
· 5+ years in manufacturing QA position (preferably in the medical device industry).
· Experience dealing with service and customer related quality issues.
· A minimum of 8 years relevant work experience.
· Experience with process and product validation industry standards · Experience in statistical techniques · Knowledge of 21 CFR Part 820, ISO and familiarity with ISO .
· Training in statistical analysis and techniques Preferred.
· Prior experience in the medical device industry.
· Prior experience regarding sterilization.
· Experience in ISO environment, training in ISO auditing.
· Advanced ASQ certifications, such as CQE, CQA or CRE Other.
· This position may require up to 10% domestic travel.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.