Lead Quality Assurance Engineer
2 weeks ago
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 manufacturing teams to ensure the production of disposable medical catheters adheres to all relevant regulatory and statutory standards.
KEY RESPONSIBILITIES
• Supervise the validation processes for EO sterilization and ensure that routine sterilization practices comply with regulatory requirements.
• Assist in environmental monitoring and cleanroom verifications as per the established schedule and support investigations of any excursions.
• Evaluate 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 oversee test method validation efforts to guarantee accurate and dependable testing procedures.
• Formulate, review, and approve inspection plans, Device History Records (DHR), and product specifications for new offerings.
• Develop and implement quality plans as necessary to ensure compliance with product and process standards.
• Initiate activities focused on 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).
• Support the New Product Development team in their initiatives.
• Lead the resolution of quality challenges 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 enhancement within the quality system and product offerings.
• Ensure the accuracy and verification of Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR).
• Oversee the calibration and preventive maintenance program as needed to maintain equipment precision and 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 similarly regulated industries.
KNOWLEDGE, SKILLS, AND ABILITIES
• Proven 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.
• Proficient in reviewing and interpreting technical drawings.
• Experience with Risk Management Records and Risk Analysis.
• Competence in conducting test method validation and Gage R&Rs.
• Understanding of statistical methodologies such as normality analysis and tolerance analysis, with the ability to analyze and interpret data confidently.
• Proficient in Minitab or similar statistical software.
• Expertise in EO sterilization is preferred (ISO 11135).
• Knowledge of biocompatibility standards is advantageous (ISO 10993 and related variants).
• 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.
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