We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

There is a pre-identified candidate; however, all applications will be reviewed.

Key Responsibilities:

• Essential Functions/Duties & Responsibilities, as follows:

o Exercise initiative and ingenuity to deal with varying circumstances, changing conditions and proceed when general instructions and established methods indicate action to be taken, referring unusual problems to supervisor performing activities.

o Assures optimum control of quality so that raw material and/or finished products conform to existing requirements, thus assuring process performance and compliance against Ethicon's Quality Systems Regulation (QSR), Good Manufacturing Practice (GMP) and ISO requirements for the manufacturing process.

o Performs raw material, tooling and/or in-process tests and reviews.

o Read and report results, performs trend analysis as required.

o Recommends and amends sampling procedures, test methods, standard operating procedures, and/or inspection measures in order to lean processes or simplify current practices.

o Utilize document change control system to own periodic review and Standard Operating Procedure (SOP) revisions.

o Performs non-conformance investigations including documentation within the non-conformance, CAPA and internal audit systems.

o Utilize failure analysis tools (i.e. 5M analysis) to conduct robust investigations.

o Support Kaizen's with cross-functional teams to ensure causes of non-conformance are identified and understood and that sound corrective/preventive actions are implemented.

o Cross-trains to support other functional areas.

o Provide training and education to peers and support groups as needed.

o Assist Quality Engineer on day-to-day activities.

o Support internal and external audits and inspections.

o Support special projects.

o Plan and organize assignments to ensure completion of projects in a timely fashion after receiving minimal instructions as to content and objective.

o Meets functional area goals and yearly strategic imperative project timelines.

o Comply with all applicable quality management system, environmental, safety and occupational health policies. (example, ISO 13485, ISO14001 & OSHAS18001).

o Performs other work-related duties assigned by QA Manager of Operations or Quality Engineer.

o Maintain strong partnerships with Manufacturing, Engineering, Quality Assurance and maintenance teams.

o Comply with company policies, procedures and the intent of the company Credo.

o Comply with established safety procedures and policies, with the intent of maintaining a safe working environment. Keep area clean and orderly.

o Understand and comply with permit/regulatory requirements.

o Coordinate material disposition inspections, process operations and non-conforming material movement from other departments and throughout the designated area. Place an emphasis on meeting customer demands.

o Support, understand and adhere to continuous improvement principles by identifying, evaluating and resolving problems.

o Support continuous improvement, improved cycle times, safety, cost reductions and customer satisfaction.

o Complete training programs and certifications as required.

• In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

o Responsible for communicating business related issues or opportunities to next management level

o 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

o Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

o Performs other duties assigned as needed

Qualifications

Education:

• A minimum of a High School diploma, G.E.D. or equivalent required.

• Associate's degree in Engineering or a related technical discipline is preferred

Experience and Skills:

Required:

• A minimum of 2 years of related quality assurance experience (Manufacturing, Production, Engineering, Quality) in a regulated environment is preferred.

• Experience in the QSR/ISO regulated Medical Device industry is preferred

• Must be proficient in the preparation of technical reports and presentations.

• Knowledge of Microsoft Word, Excel and Outlook required.

• Must have strong communication, interpersonal and influencing skills.

• Must have strong analytical problem-solving skills.

• Must be self-motivated and capable of completing job duties with limited supervision.

• Maturity and ability to display a high level of professionalism is required.

• The ability to interact with technical peers, manufacturing associates and all levels of management in a cross-functional team environment is required.

• Must be able to speak, comprehend, and write English.

• Knowledge of Good Manufacturing Practices (GMPs) preferre d.

• Knowledge of JD Edwards (ERP), Laboratory Information Management Systems (LIMS) and System Control and Data Acquisition (SCADA) preferred.

• ASQ certification is preferred.

• Experience with investigation tools (e.g. DMAIC, Fishbone Analysis, 5 Whys) preferred.

• Knowledge of statistical data analysis tools (e.g. Minitab) preferred.

• Knowledge of Process Excellence/Six Sigma concepts/tools is preferred.

Preferred:

• Must be proficient in the preparation of technical reports and presentations.

• Knowledge of Microsoft Word, Excel and Outlook required.

• Must have strong communication, interpersonal and influencing skills.

• Must have strong analytical problem-solving skills.

• Must be self-motivated and capable of completing job duties with limited supervision.

• Maturity and ability to display a high level of professionalism is required.

• The ability to interact with technical peers, manufacturing associates and all levels of management in a cross-functional team environment is required.

• Must be able to speak, comprehend, and write English.

• Knowledge of Good Manufacturing Practices (GMPs) preferre d.

• Knowledge of JD Edwards (ERP), Laboratory Information Management Systems (LIMS) and System Control and Data Acquisition (SCADA) preferred.

• ASQ certification is preferred.

• Experience with investigation tools (e.g. DMAIC, Fishbone Analysis, 5 Whys) preferred.

• Knowledge of statistical data analysis tools (e.g. Minitab) preferred.

• Knowledge of Process Excellence/Six Sigma concepts/tools is preferred.

Other:

• Travel: No

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

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 based on disability.

There is a pre-identified candidate; however, all applications will be reviewed.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.