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Senior Quality Systems Engineer

Redwood City, CA
Title: Senior Quality Systems Engineer
Location: Redwood City, CA

Job Responsibilities:
  • Ensure Quality System conforms to the Quality System Regulations (QSR), ISO 13485, MDD, MDR, CMDR, PAL, other applicable regulations and standards, corporate and sector requirements.
  • Identify, lead, and implement Quality System Improvements in conjunction with Quality Management.
  • Develop and provide Quality System processes training.
Audit Leadership:
  • Create and maintain internal audit schedules.
  • Perform audits as needed.
  • Manage internal audit schedules so the frequency of audits is commensurate with the importance of the activity, the difficulty of the activity to perform, and the problems found.
  • Support internal audit program when needed.
  • Support external regulatory agency audit activities as assigned.

CAPA Leadership

  • Manage CAPAs, lead CAPA review board meetings and assure effectiveness of CAPA system.
  • Proven understanding and application of quality tools, methodologies, and software (i.e., Is/Is Not Analysis, 5 Whys, Cause and Effect Diagram, Process Mapping, Pareto Analysis, Minitab, etc.) in the areas of investigations and CAPAs.
  • Monitor and track the implementation of corrective action/preventive action (CAPA) as result of internal and external audits (FDA, BSI, etc.) and reports progress to management on a routine basis.
  • Lead a team of CAPA investigators and CAPA analysts with members from multiple functional areas in the performance of CAPA actions and determining the effectiveness of the actions.
  • Lead the CAPA Review Board (CRB) process; executes Quality signatory authority for the review and disposition of nonconforming product in accordance with regulatory requirements.
  • Review CAPA investigations to ensure that documents are thorough, complete, and timely.
  • Prepare monthly metrics for CAPA, Training, Complaints, Engineering Change Orders, NCMRs and other Quality System processes as requested.
  • Establish and drive strategies to achieve site and division quality and compliance goals with regards to the CAPA investigations and the CAPA metrics program. This includes the establishment of Quality System policies and procedures as needed to ensure compliance.
  • Work closely with senior management and colleagues to ensure the CAPA department provides a responsive, efficient, and effective service to customers.

Systems Analysis

  • Develop, analyze, prioritize, and organize to implement Quality System improvements as company expands by providing technical expertise in system requirement and specifications.
  • Manage Quality System files and databases to ensure information is accessible and accurate (ex. CAPA Tracking Log).
  • Compile Quality System trend data and present at Management Review Meetings.
  • Maintain and present Key Performance Indicators (KPI) data to management.

Statistical Controls

  • Manage quality system training on statistical methods to ensure appropriate statistical methodology is applied where necessary to detect recurring quality problems.
  • Evaluate and recommend QA sampling plans based on desired confidence limits, process capabilities and manufacturing/inspection methods and equipment.
  • Provide technical expertise in experimental design, data analysis, sampling techniques, and other QA engineering areas.
  • Compile Quality System trend data, prepare presentation of the data at Quarterly Management Review Meetings.
  • Prepare monthly metrics for CAPA, Training, Complaints, Engineering Change Orders, NCMRs and other Quality System processes as requested.
  • Maintain and present Key Performance Indicators (KPI) data to management.
Qualifications:
  • At least seven years of QS or QC related experience in FDA/GMP regulated industry
  • BS Degree
  • ISO-13485 Lead Auditor certification
  • Training in EU MDR auditing and regulations preferred
  • Advance knowledge and understanding of Quality Systems and applicable GMP regulations and standards
  • Extensivce experience with the CAPA and Internal Audit programs. Program ownership/management experience preferred.
  • Effective written and oral communication skills and ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
  • Ability to effectively present information in one-on-one and group situations to customers, clients, and other employees of the organization
  • Ability to work with mathematical concepts such as probability and statistical inference
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
  • Effective time management and interpersonal skills
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