SR QUALITY ENGINEER COMPLIANCE Job in Irvine, California US

Advanced Sterilization Products Division of Ethicon, Inc., a member of Johnson Johnson's Family of Companies, is currently recruiting for a Senior Quality Engineer, Compliance, located 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 Senior Quality Engineer, Compliance is responsible for the establishment and maintenance of processes pertaining to regulatory compliance and quality systems to ensure regulatory requirements for compliance. The Senior Quality Engineer, Compliance will collaborate with business partners to ensure compliance to all regulatory and standard requirements. Specific areas of focus will be: Compliance and Training: Ensure that the compliance requirements (Guidance documents, standards, etc.) are up to date and lead organization-wide training on updated requirements. Management Review: Will monitor all sources of quality data to ensure that appropriate review and escalation through risk management system. Will lead the QS management review process in the compilation, final approval, and presentation of T1 and T2 management review quality data. Will be responsible for coordinating cross functional teams and QS metrics reporting, to ensure compliance with defined procedures. Will develop and help implement new metrics related to performance across all aspects of systems and processes. Will train process owners to new metrics and implementation. Field Action: Provide support/backup to the Compliance Manager on all Field Action activities including ASP correspondence to the FDA. Will lead and track action items related to Field Actions. External and SI/Customer Audit Support: Manage and coordinate all external and SI audits. Will serve as audit and Front Room management. Internal Audits: Establish and lead an internal audit program to ensure compliance across all departments within the organization. Plan, execute and follow up on audit activities. Quality Review Boards (QRB): Identify and facilitate issues based on metrics reported to ensure that product issues are appropriately escalated to QRB in efficient and timely manner .Special Projects and Base Business: 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. She/ He will work with 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. Quality System Back-up Support: Assist in the development and implementation of new (and improvements to) quality systems. Provide back-up support to the Quality Systems department as appropriate. Office environment and (where appropriate) This position does not have direct reports.

Qualifications

A minimum of a Bachelors degree in an Engineering or Life Science discipline or related technical field is required. A minimum of 5 years of related experience in a quality systems role is required. A minimum of 5 years experience working in a medical device industry strongly preferred. Working knowledge of 21 CFR Part 820, QSR, ISO 13485, and MDD/IVDD requirements is a must. A minimum of 3 years experience supporting FDA audits is strongly preferred. A minimum of 3 years experience supporting external audits from Customers or Notified Bodies preferred. Ability to interpret and apply regulatory requirements and industry best practices is required. An experienced Internal/External Auditor and/ or an ASQ CQA certification is preferred; An experienced Quality System/Compliance Engineer and/ or ASQ CQE certification preferred; A minimum of 3 years experience with Recalls/Field Action management activities is a preference. A minimum of 3 years experience working with Risk Analysis and Risk Management required. Excellent Investigative skills such as analytical problem solving, fish bone, root cause analysis, etc. required. Excellent computer (e.g., PowerPoint, WORD, Excel, Visio) is required, Excellent analytical skills and ability to develop new metrics is required. Ability to work autonomously on specific compliance or quality systems projects with accelerated timelines and base business activities required. The successful candidate must be a critical thinker, detailed oriented, while overseeing multiple tasks for several projects or base business deliverables. Experience providing project support to senior and executive management. Excellent communication skills, both written and verbal are required. This position will require up to 10% travel. This position will be based in Irvine, CA.

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