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QA Materials Specialist - 2406195041W

Description

Ethicon, a member of the Johnson & Johnson Family of Companies, is recruiting for QA Material Specialist. This position will be based at the San Lorenzo facility for approximately 3 months following the start date. Subsequently, the position will be based at the Manatí facility. Ethicon is expanding its manufacturing operations to Manatí, Puerto Rico. Resources hired will work in San Lorenzo temporarily until the Manatí Manufacturing Facility is operational.

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/.

Reports to Quality Team Leader, Quality Leader, Quality Lead or designee and with the objective of maintaining high quality standards for the product manufacturing process and the compliance with the regulatory requirements, supports and maintain OPCERT program, performs data analysis to support process improvements and decision making and performs other functions to support the Quality Assurance Department at Ethicon LLC. Engage in the Quality Assurance operation in accordance with the QSR, ISO and Ethicon written specifications and quality standards. Support cost improvement projects at plant level and prepare reports (using the computer system) as assigned. Maintains control of materials submitted for evaluation, conducts inspections of raw materials and recommends final disposition.

Responsibilities:

• Responsible for coordination of hold material and track and report of hold trends.

• Perform data analysis and recommend disposition of materials.

• Evaluate and make recommendations on day-to-day manufacturing QA related issues.

• Participate in non-conformances’ investigations and root cause analysis.

• Support Engineering and QA Departments in projects and validation activities.

• Support the effective implementation of programs that help improve the overall quality of product and process within area of responsibility.

• Support the OPCERT PROGRAM, may include coordinating and provide training to associates on inspection and disposition of product. Update and maintain training material for inspection and disposition of product.

• Verifies completion of operator certification requirements for associates and request operator certification.

• Perform visual and dimensional inspections using test and inspection equipment following applicable procedures to determine the material disposition.

• Maintain the control of raw materials under evaluation, and after evaluation.

• Send samples to supplier for further evaluations as needed.

• Notify raw materials nonconformance to Supplier Quality Management and support investigations.

• Maintain control of nonconforming raw materials, following applicable procedures.

• Support Plant operations in solving raw material issues affecting the manufacturing process.

Qualifications

• Associate degree with four (4) years of experience within the Quality Department in regulated industry is required or Bachelor’s Degree (Science or Technical Field preferred) with two (2) or more years of experience within Regulated Industry is required.

• Availability to work overtime, various work schedules, which may include 1st, 2nd, 3rd shifts and/or 12-hour daily shifts, including weekends and holidays is required.

• Intermediate or higher computer skills and use of software application(s) is required.

• Bilingual (Spanish & English) is required.

• ASQ CQT is preferred.

• ASQ CQA is preferred.

• Knowledge of QSR and ISO Standards is required.

• Availability to travel 10% of the time between Ethicon Locations and other locations (domestic and international travel) is required.

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 .

Primary Location NA-US-Puerto Rico-Manatí

Other Locations NA-US-Puerto Rico-San Lorenzo

Organization Ethicon Endo Surgery, LLC (7597)

Travel Yes, 10 % of the Time

Job Function Quality Control

Req ID: 2406195041W