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Lead Quality Assurance Engineer

2 months ago

Carlsbad, United States Bolt Medical Full time

IMPORTANT NOTICE FOR CANDIDATES

DIRECT APPLICATIONS ONLY, PLEASE DO NOT SEND MESSAGES.

ROLE OVERVIEW

The Senior Quality Engineer at Bolt Medical is tasked with delivering exceptional quality engineering support and guidance for the development and execution of manufacturing processes. This role collaborates closely with the manufacturing team to ensure the production of disposable medical catheters adheres to all relevant regulatory and statutory standards.

KEY RESPONSIBILITIES

  • Manage EO sterilization validation processes, ensuring that routine sterilization operations comply with regulatory benchmarks.
  • Assist in environmental monitoring and cleanroom verifications as per the established schedule, and support investigations into any excursions.
  • Review and endorse manufacturing validation test plans, protocols, and reports.
  • Lead the completion of risk management deliverables, including process Failure Mode and Effects Analysis (pFMEA) and Control Plans.
  • Support and spearhead test method validation activities to guarantee precise and dependable testing processes.
  • Develop, review, and approve inspection plans, Device History Records (DHR), and product specifications for new offerings.
  • Create and implement quality plans as necessary to ensure compliance with product and process standards.
  • Initiate activities aimed at defect prevention and detection throughout the manufacturing process.
  • Provide statistical support, expertise, and analytical problem-solving for process validations and engineering protocols.
  • Assist with Management Reviews, internal and external audits, deviations, Corrective and Preventive Actions (CAPA), Non-Conformance Reports (NCR), Supplier Management, and Returned Goods Authorization (RGA).
  • Support the New Product Development team in their initiatives.
  • Lead the resolution of quality-related issues associated with NCRs and CAPAs.
  • Ensure adherence to quality system procedures and all regulatory obligations.

TECHNICAL EXPERTISE

  • Provide technical guidance regarding component schematics and inspection requirements.
  • Identify opportunities for improvement within the quality system and product offerings.
  • Ensure the accurate development and verification of Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR).
  • Oversee calibration and preventive maintenance programs to maintain equipment accuracy and reliability as needed.
  • Manage supplier quality activities, including audits, performance assessments, and quality agreements when required.

EDUCATION AND EXPERIENCE REQUIREMENTS

  • Bachelor's degree in a scientific or engineering discipline, or an equivalent combination of education and experience.
  • A minimum of 5 years of relevant experience in the pharmaceutical, medical device, or similarly regulated industries.

KNOWLEDGE, SKILLS, AND ABILITIES

  • Experience in catheter design and production, or similar medical devices, within a quality-focused environment is essential.
  • Familiarity with GMP practices in ISO 13485, ISO 14976, and FDA 21 CFR Part 820 settings.
  • Ability to review and interpret technical drawings.
  • Experience with Risk Management Records and Risk Analysis.
  • Proficient in test method validation and Gage R&Rs.
  • Understanding of statistical techniques such as normality analysis and tolerance analysis, with the ability to analyze and interpret data confidently.
  • Proficient in Minitab or similar statistical software.
  • Preferred expertise in Sterilization (EO) per ISO 11135.
  • Knowledge of biocompatibility standards (ISO 10993 and variants) is advantageous.
  • Strong analytical, planning, and organizational capabilities.
  • Excellent interpersonal and communication skills, both oral and written.
  • Self-motivated with the ability to work independently under pressure and adapt to changing priorities.
  • Proficient in MS Office applications including Word, Excel, PowerPoint, Project, and Visio.