Lead Quality Assurance Engineer

2 weeks ago

Carlsbad, United States Bolt Medical Full time

IMPORTANT NOTICE FOR CANDIDATES

RECRUITERS: PLEASE DO NOT REACH OUT.

POSITION OVERVIEW

The Senior Quality Engineer at Bolt Medical is tasked with delivering quality engineering expertise and direction for the development and execution of manufacturing processes. This role involves close collaboration with manufacturing teams to ensure the production of disposable medical catheters adheres to all relevant regulatory and statutory standards.

KEY RESPONSIBILITIES

  • Manage EO sterilization validation procedures and confirm that ongoing sterilization operations comply with regulatory requirements.
  • Assist in environmental monitoring and cleanroom validations, and support investigations into any excursions.
  • Evaluate and endorse manufacturing validation test plans, protocols, and reports.
  • Lead the execution of risk management deliverables, including process Failure Mode and Effects Analysis (pFMEA) and Control Plans.
  • Oversee test method validation initiatives to guarantee reliable and precise testing processes.
  • Formulate, review, and approve inspection plans, Device History Records (DHR), and product specifications for new offerings.
  • Design and implement quality plans as necessary to ensure compliance with product and process standards.
  • Develop strategies aimed at identifying and preventing defects during manufacturing.
  • Provide statistical support 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.
  • Facilitate the resolution of quality-related issues concerning NCRs and CAPAs.
  • Ensure adherence to quality system procedures and all regulatory mandates.

TECHNICAL EXPERTISE

  • Provide technical guidance on component schematics and inspection requirements.
  • Identify opportunities for enhancements within the quality system and product lines.
  • Ensure the accuracy 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 reliability.
  • Manage supplier quality activities, including audits, performance evaluations, and quality agreements as necessary.

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 other highly regulated sectors.

SKILLS AND QUALIFICATIONS

  • Experience in catheter design and production, or similar medical devices, within a quality context is essential.
  • Familiarity with GMP practices in ISO 13485, ISO 14976, and FDA 21 CFR Part 820 environments.
  • 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, including normality and tolerance analysis, with the ability to analyze and interpret data confidently.
  • Proficient in Minitab or other statistical software.
  • Preferred expertise in Sterilization (EO) according to ISO 11135.
  • Knowledge of biocompatibility standards (ISO 10993 and variants) is advantageous.
  • Strong analytical, planning, and organizational skills.
  • 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.

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