Ethicon Inc. (a member of Johnson & Johnson Family of Companies) is currently seeking a Technician Quality Assurance IV Coordinator to join our outstanding Quality team located in San Angelo, TX!
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/.
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For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
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.
Senior support individual contributor that drives tasks that are typically not routine. Coordinates administrative, interpersonal, testing methodologies and inspection support activities for the Quality department. Performs Quality Operations and maintenance tasks and participates in developing new testing and inspection procedures. Helps supervise and maintain documentation of quality tests, audits, and inspections in accordance with regulatory and organizational requirements.
Key Responsibilities:
- Exercise initiative and resourcefulness 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.
- Assures optimum control of quality for raw material and tooling inspection and/or finished products in accordance 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.
- Management of quarantine cages.
- Recommends, amends and analyzes sampling procedures, test methods, standard operating procedures, and/or inspection measures in order to lean processes or simplify current practices.
- Uses document change control system to build, modify or revise Standard Operating Procedure (SOP's).
- Performs quality walkthroughs, non-conformance investigations for non-conformances, CAPA and internal audit observations.
- Lead Kaizen's and Proactive Quality activities for overall improvements from a Quality Assurance and Quality Operations perspective.
- Performs other work-related duties assigned by QA Operations Manager. Assist Quality Engineer on day-to-day activities.
- Supports internal and external audits and inspections.
- Complete training programs and certifications as required.
- Demonstrates Johnson & Johnson's Leadership Imperatives and Credo in day-to-day interactions with team.
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 six (6) years of related Quality Assurance experience (Manufacturing, Production, Engineering, Quality) required, experience in a regulated environment is preferred.
- Must be proficient in the preparation of technical reports and presentations.
- Knowledge of Microsoft Word, Excel and Outlook required.
- Knowledge of SAP, Laboratory Information Management Systems (LIMS), ADAPTIV.
- Must have strong communication, interpersonal and influencing skills and 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 and the ability to interact with technical peers, manufacturing associates and all levels of management in a cross-functional team environment.
Preferred:
- Knowledge of Good Manufacturing Practices (GMPs) preferred.
- Experience with investigation tools (e.g. DMAIC, Fishbone Analysis, 5 Whys) preferred.
- Knowledge of statistical data analysis tools (e.g. Minitab) preferred.
- Experience in the QSR/ISO regulated Medical Device industry is preferred.
- Knowledge of Process Excellence/Six Sigma concepts/tools is preferred.
- ASQ certification is preferred.
Other:
- This position will be located in San Angelo, TX and may require up to 10% domestic or international travel.
- The ability to work overtime, off-shift hours and some holidays as needed by business is required.
- Must be able to proficiently communicate both written and orally in English.
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.