Staff Quality Engineering (NPI / LCM)

Johnson & Johnson Sterilmed a member of the Johnson & Johnson Family of Companies is currently recruiting for a Staff Quality Engineer, New Product Intervention & Life Cycle Management (NPI/LCM )! 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:

Applies intermediate Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, and industry best practices to assignments. Plans and conducts projects and assignments with technical responsibility or strategic input. Receives intermittent, moderately detailed instructions from technical Quality leaders at various levels, in addition to other stakeholders.

• New Product Team Support for quality system design and audit

• Lifecycle support of steady state manufacturing processes, change control, signal detection/escalation, and CAPA.

Key Responsibilities:

• Develop measurement systems to monitor effectiveness of QA and reliability systems to identify, bracket, correct and prevent defects to demonstrate continuous improvement to management.

• Maintain alertness to changes in the industry and regulatory environments and apply this information to business practices.

• Provide support and expertise in the implementation and enforcement of GMP, ISO and FDA (Food and Drug Administration) requirements.

• Prepare QA (Quality Assurance) system and assist in technical issues for manufacturing processes that are to be transferred to satellite facilities.

• Manage established processes in support of steady state manufacturing in accordance with defined QA program for product transfers.

• Provide statistical support and expertise in DOE (Design of Experiments) and analytical problem solving for manufacturing, technical services and product development in order to:

• Minimize sample and scrap waste.

• Assess reliability and risks based on data presented.

• Identify root cause of problems.

• Reduce and identify sources of variation.

• Audit and approve manufacturing, quality, engineering and validation / qualification documents for conformance to company business practices and departmental procedures.

• Support development of validation strategy

• Act as liaison to Regulatory Affairs department to perform initial regulatory review of all engineering changes / modifications to products.

• Perform analysis of documents / information to ensure that all critical product characteristics have been identified and properly evaluated:

• Design specification o FMEA (Failure Mode Evaluation and Analysis): Product and Process Material Specification o FGI I Sheet / P-Sheet

• QA system (in line control points) - FGI results

• Product inquiry analysis

• Reliability analysis

• Provide sampling plans and approve inspection, methods for evaluation and testing of components and products.

• Support Continuous Release program, where applicable to reduce need for FGI inspection.

• Provide support and expertise in reliability strategy and reliability growth demonstration during new product development.

• Other responsibilities may be assigned & not all responsibilities listed may be assigned.

• 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 procedure.

Qualifications

Education:

A minimum of a Bachelors or equivalent University degree is required.

Required:

• A minimum of 6 years relevant work experience.

• Experience in auditing for compliance to ISO or GMP standards or more years related experience.

• Intermediate knowledge of Quality Engineering/Scientific methods and techniques.

• Fundamental technical understanding of manufacturing equipment and processes.

• Experience managing projects and demonstrating project leadership abilities.

• Expertise in measuring techniques (for example, mechanical, optical, gages, automation).

Specialized Q&C Competencies:

• Production and Processing Systems

• Qualification and Validation

• Product Design Support

• Quality Statistics, Data Analysis and Tools

• Product Control and Disposition

• Product Development Support

• Technical Transfer & Scale Up

• Predictive Analytics / Reliability

Other:

• This position may require up to 10% domestic travel.

• Re-location funding is available!

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.