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Sr. Supplier Quality Engineer

Company: Gables Search Group
Location: Fremont
Posted on: July 19, 2021

Job Description:

Sr. Supplier Quality Engineer-Fremont CA    No Sponsorship or relocation available

Front line management is reporting to the Director, Quality and Regulatory Compliance; supporting and being responsible for the compliance, QA and QC activities in their assigned value stream to provide customers with safe and effective products as directed by the QMS.

Minimum Qualifications:

  • Bachelor’s Degree in Chemistry, Life Sciences, Applied Medical, or related field of study.
  • Minimum of 8 years of experience in a highly regulated environment, such as diagnostics, pharmaceutical, biotechnology, or medical device, with at least 4 years of Design Assurance, Compliance, and/or Quality experience.
  • Minimum of 10 years of experience in a supervisory capacity or managing teams within matrix environment is required.
  • Knowledge of and experience with FDA regulatory requirements concerning class I, II, and III devices including: design control, validations, MDRs, 510(k) submissions (PMNs), PMAs, IDEs, INDs, NDAs, and other pertinent issues
  • Extensive knowledge of QSR/QMS to support cGMP, GLP, GCP, CE-IVD, ISO-9001, ISO-13485, MDSAP, IVDR, Etc.
  • Familiar with manufacturing techniques, project management and formal continuous process improvement techniques (Lean Manufacturing)
  • Ability to closely partner with customers to adapt the management system and manufacturing methods to meet requirements while ensuring regulatory compliance.

Responsibilities:

  • These responsibilities will apply of the Fremont, CA and or other CDD sites and their quality management systems
  • Oversee a high performing Quality, Regulatory and Compliance team by hiring and developing strong team members and leaders, establishing and actively managing performance expectations, and providing development opportunities to staff
  • Support regulatory strategies throughout lifecycle of products as appropriate.
  • Assure timely, accurate and efficient management of Quality Assurance operation, including accurate document controls, timely design controls, and up-to-date revision controls for product manufacturing, testing and releasing procedures, as well as product labeling and package inserts
  • Oversee Quality Control team performance to meet standard turnaround times, reduce the cost of poor quality, reduce and mitigate backorders, and improve the compliance to the site Quality Management System
  • Ensure effective management of the Quality Management System including assuring effective management reviews, complaint handling, CAPA system, change control, calibration maintenance, process validation, internal auditing, R&D transfers, and manufacturing area support
  • Ensure products comply with the regulations of all applicable regulatory agencies
  • Maintain company activities in compliance with Quality System Regulations (cGMP), CE-IVD-IVDR, ISO 13485 and other appropriate regulations
  • Ensure Quality Systems are effectively maintained to achieve strong levels of cGMP/ISO compliance
  • Stay current and apprised of changing international legislation, guidelines and customer practices
  • Work with Marketing to approve commercial literature and language, customer communications
  • Advise scientists and manufacturing teams on quality requirements
  • Review company practices and provide advice on changes to systems, processes and procedures. Participate in PPI events, where appropriate.
  • Develop, implement, and improve quality programs to meet worldwide standards for efficacy, safety and quality
  • Support and interact with regulatory agencies and auditors from OEM customers on matters related to quality system management (internal, external, customer audits)
  • Coordinate and manage all corrective actions including audit findings, customer complaints, non-conformance action (NCAR) and corrective and preventative action (CAPA)
  • Establish and manage effective employee training programs related to GMP, PCO, ISO regulatory requirements, EH&S related requirements, and NCAR and CAPA management
  • Oversee the review of job codes and timely training for the value stream/team.
  • Provide support and communications for tier boards supporting product delivery and quality events under the QMS within the value stream
  • Support JDI, Gemba walks and PPI activities to assure continuous improvement and employee and product safety
  • Establish metrics and their reporting per the tier boards, QMS and management review
  • Oversee all QC activities in your assigned value stream supporting the value stream QC supervisor owned items including material, in process and finished product testing and disposition as well as the value assignment where needed and stability or product surveillance; drive resolution of value stream issues to conclusion; escalate issues with product or personnel
  • Oversee and support the QA activities per the QMS including, audits, variances, CAPA, NC, OEM SCARS, complaints, changes and risk management
  • Perform document controls and approvals in the electronic document management system as appropriate
  • Support and drive cross functional and cross value stream teams, quality events and projects

The Sr. Manager, Quality Assurance will ensure the appropriate compliance of all appropriate in vitro diagnostic device products in order to control the safety and efficacy of the products. The key to this role will be a deep understanding of how quality is assessed by the US Food and Drug Administration (FDA), IVDD and IVDR/CE-marking, China CFDA, MDSAP, and other major regulatory agencies, as applicable to quality management systems, including design controls.

Keywords: Gables Search Group, Fremont , Sr. Supplier Quality Engineer, Other , Fremont, California

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