Quality Control Manager

7 days ago

Santa Clara, California, United States Cirtec Medical Full time
Job Summary

The Principal Quality Engineer will be responsible for developing, establishing, and maintaining quality engineering methodologies, systems, and practices that meet customer and regulatory requirements. This role will focus on leading quality engineering support to the new product development process, operations/production, and quality systems.

Key Responsibilities
  • Provide quality engineering support for engineering product development and sustained manufacturing of catheters.
  • Develop and justify appropriate sampling plans with characterization of test/inspection methods.
  • Author, review, and/or approve documentation for Design Control activities for Design and Project Phase Reviews as well as Product Verification testing in cooperation with cross-functional engineering teams.
  • Assist in qualification activities associated with supplier/vendor design characterization requirements for projects, to include audits and assessments.
  • Provide leadership engineering technical expertise and guidance for site-level quality functions.
  • Support and enforce quality best practices and GDP/GMP continuous improvement efforts.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPA-s, CCR-s, and NCMR-s.
  • Ensure quality requirements are communicated and met at suppliers.
  • Review manufacturing records to perform lot release activity for catheters, including COC issuance.
  • Provide quality project management support as needed for product transfers from development to validation to production.
  • Verification/validation system owner responsible for the development and management of the verification/validation master plan along with the verification/validation determination.
  • Develop and maintain standard operating procedures.
  • Develop and maintain project quality plans for assigned projects.
  • Develop protocols, perform statistical analyses, and write reports for validations and formal product/process development, which requires quality-engineering involvement.
  • Lead the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols, and equipment calibration/maintenance to ensure compliance with the quality system.
  • Ensure compliance of all site personnel to corporate and site-level QMS and training requirements.
  • Administration of employment practices, which includes, but is not limited to, monitoring time & attendance, hiring, terminating, counseling, and disciplinary actions for all employees. Responsible to ensure these actions are performed in compliance with federal, local, and organizational laws/policies.
  • CAPA (Corrective and Preventative Action) system owner or support responsible for the support of the corrective action system and procedures.
  • Interact with customers and suppliers to resolve CAPA and complaint investigations.
  • Approve disposition of material via NCRs.
  • Own or approve supplier quality activities, including supplier approval and maintaining and assessing supplier performance data (i.e. SCAR/on time).
  • Provide audit support for third-party audits, customer audits, and internal audits.
  • Support the implementation of continuous improvement initiatives.
  • Develop and maintain control plans.
  • Initiate and maintain SPC (Statistical Process Control) for production processes.
  • Lead FMEA (Failure Modes & Effects Analysis), and DOE (Design of Experiment) as applicable.
  • Complies with company, quality, and safety standards, policies, and procedures.
Requirements
  • Bachelor of Science, preferably in biomedical, mechanical, or materials engineering discipline.
  • 10 years minimum experience in medical device environment, catheter experience preferred. Or combination of education and relevant work experience.
  • Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
  • Must possess excellent verbal communication, organizational, and management skills.
  • Training or equivalent experience in computer use and software-Microsoft Word, Excel, PowerPoint, and Access. Minitab experience desirable.
  • Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.
  • Must be able to analyze and process information; promote process improvement, developing standards, managing processes, manufacturing methods, and procedures; and supports innovation.

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