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Irvine, CA, US

SENIOR RECALL SPECIALIST, COMPLIANCE-9134121109

Description

Advanced Sterilization Products (ASP) Division of Ethicon, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for Senior Recall Compliance Specialist in Irvine, CA.

ASP (Advanced Sterilization Products), a member of the Johnson & Johnson Family of Companies, is a leading designer and developer of innovative instrument sterilization, high-level disinfection and cleaning technologies. The company is dedicated to providing infection prevention solutions that create the safest possible environments for patients, healthcare providers, and communities. ASP is based in Irvine, California with offices around the world. For more information, please visit www.aspjj.com or follow us at www.Twitter.com/aspjj.

The Recall Specialist, Compliance is responsible for the coordination, execution and maintenance of the field action process pertaining recalls and/or field corrections.

The Recall Specialist, Compliance will collaborate with business partners to ensure compliance to all regulatory and standard requirements specifically in accordance with recall and field correction activities. Specific areas of focus will be:

Manage all Field Action activity as a result of Quality Review Boards, Health and Hazard Evaluations. Develop and execute ASP correspondence to the FDA in accordance with 21 CFR Part 806, manage Field Action Strategy Team meetings, and communicate with corporate and regulatory agencies. Track action items related to Field Actions to completion. Coordination and communication of recall activities throughout all regions and countries. Ensure all field action documentation is maintained and up to date per requirements identified in SOP's. Support company initiatives with respect to process improvements to recall procedures. Working knowledge of project management techniques like Six Sigma, CPM and a strong understanding of statistics. Proven track record with Health Hazard Evaluations, Quality Review Board activities and experience with risk management methodologies such as Design and Process FMEA, FTA. Ensure that the compliance requirements (Guidance documents, standards, etc.) are up to date. Metrics include (but are not limited to) number of field actions to date, costs associated with field actions and status of field actions.

Under general supervision establish and maintain quality system and compliance program, procedures and controls to ensure that the performance and quality of product conforms to the established processes and procedures. Work product quality engineering, operations engineering and research & development to review and ensure adherence to established procedures. Provide compliance and quality system support of special projects directed by the Compliance & Quality Systems Director, Compliance Manager, or Quality Systems Manager. Additional base business support will include activities identified by the Compliance Manager. Assist in the development and implementation of new (and improvements to) quality systems. Provide back-up support to the Quality Systems department as appropriate.

Qualifications


Must possess a Bachelors Degree in an Engineering or Life Science discipline or related technical field

This position requires 5 + years of related experience in quality systems role. The position also requires 5+ years experience in working in the medical device industry. A working knowledge of 21 CFR Part 820, QSR, ISO 13485, and MDD/IVDD requirements is required. 3+ years experience supporting FDA audits is required. 3+ years experience supporting external audits from customers or Notified Bodies is preferred. The ability to interpret and apply regulatory requirements and industry best practices is preferred. Experience working as an Internal/External Auditor is preferred. Experienced Quality System/Compliance Engineer is preferred. An ASQ CQE certification preferred. 3+ years experience with Recalls/Field Action management activities both within and outside of the United States is preferred. 3+ years experience working with Risk Analysis and Risk Management is preferred.

The ability to work autonomously on specific compliance or quality systems projects with accelerated timelines and base business activities is preferred. The ability to think critically and remain detail oriented, while overseeing multiple tasks for several projects or base business deliverables is preferred. Project Management skills and experience with managing small to medium size projects with cross-functional teams are preferred. Excellent Investigative skills such as analytical problem solving, fish bone, root cause analysis, etc are preferred. Excellent computer (e.g., PowerPoint, WORD, Excel, Visio), communication, and written skills are preferred. Excellent analytical skills and ability to develop new metrics are preferred. Experience providing project support to senior and executive management is preferred.

This position is located in Irvine, CA.

If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today!

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Primary Location:North America-United States-California-Irvine
Organization: Advanced Sterilization Products (ASP)
Relocation: Eligible
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