Lead Quality Assurance Engineer

1 week ago

Carlsbad, United States Bolt Medical Full time

DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.

RECRUITERS: DO NOT CONTACT.

POSITION OVERVIEW

The Senior Quality Engineer at Bolt Medical will play a pivotal role in delivering quality engineering support and guidance for the development and execution of manufacturing processes. This role will closely collaborate with the manufacturing team to ensure the production of disposable medical catheters adheres to all relevant regulatory and statutory requirements.

KEY RESPONSIBILITIES


• Supervise EO sterilization validation processes and ensure that routine sterilization operations comply with regulatory standards.


• Assist in environmental monitoring and cleanroom verifications as per the established schedule and support investigations of any excursions.


• Review and endorse manufacturing validation test plans, protocols, and reports.


• Spearhead the completion of risk management deliverables, including process Failure Mode and Effects Analysis (pFMEA) and Control Plans.


• Facilitate and lead test method validation activities to guarantee precise and dependable testing processes.


• Develop, review, and authorize inspection plans, Device History Records (DHR), and product specifications for new offerings.


• Formulate and implement quality plans as necessary to ensure compliance with product and process standards.


• Initiate activities aimed at preventing and identifying defects 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).


• Offer support to the New Product Development team.


• 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 on component schematics and inspection requirements.


• Identify opportunities for improvement within the quality system and product.


• Ensure that Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are accurately developed and verified.


• Oversee the calibration and preventive maintenance program 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.


• At least 5 years of relevant experience in the pharmaceutical, medical device, or other highly regulated industries.

KNOWLEDGE, SKILLS, AND ABILITIES


• 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.


• Proficient in reviewing and interpreting technical drawings.


• Experience with Risk Management Records and Risk Analysis.


• Competence in performing 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 using Minitab or similar statistical software.


• Expertise in Sterilization (EO) is preferred (ISO 11135).


• Knowledge of biocompatibility standards is preferred (ISO 10993 and associated variants).


• 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 quickly to changing priorities.


• Proficient in MS Office applications including Word, Excel, PowerPoint, Project, and Visio.

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