Quality Engineer

4 weeks ago

Carlsbad, United States Bolt Medical, Inc. Full time

ABOUT THE COMPANY A medical device startup company at the transition from R&D and is working on a family of therapeutic medical devices that will save people’s lives. Our company has an exciting and unique technology with clinical advantages over existing procedures. It is uniquely positioned for success and is led by veterans in the industry.

Job Summary: The position will be responsible for providing quality engineering support. This position will work closely with R&D, Manufacturing in the design and manufacture of disposable medical catheters and console in compliance with applicable regulatory and statutory requirements.

Essential responsibilities: Conduct product returned investigations and ensure rapid resolution of product investigation and/or safety issues with cross functional group Support master validation process and documentation including the validations of Production processes and tooling documentation, MVP, IQ, OQ, PQ, PPQ, and TMV Support approved Operations initiatives. Review and audit medical device records for comprehensiveness. Develop, review, and approve inspection plans and product drawings for new or modified product designs for quality characteristics Ensure that the contents of DMR and DHR are accurately developed and verified. Implement a risk-based approach to ensure product conformance with customer needs. Recommend and provide statistical support and expertise and analytical problem solving for product development and manufacturing. Lead the resolution of quality issues related to NCR and CAPA.Take appropriate actions to address the nonconformance of supplied goods and services. Develop activities that would drive prevention, detection of defects at earliest phase of product design. Assist in the investigation, root cause analysis, planning, and execution of activities within the CAPA system. Ensure robust final product testing is designed, developed, and implemented. Review all design changes to ensure that the documentation includes the necessary justifications, validation and verification updates, risk assessment etc. Supports activities related to Management Review, audits (internal and external), deviations, CAPA, NCR, supplier management, RGA, and etc. Identify improvement opportunities related to the quality system and product Responsible for compliance with quality system procedures and all regulatory requirements.

Required Knowledge and Experience: Bachelor's degree in a scientific/engineering discipline; or equivalent combination of education and experience. Minimum 2 year (QE II) or 5 year (Senior QE) of relevant work experience in either pharmaceutical, medical device, or other highly regulated industry.

Knowledge, Skills, and Abilities: Experience working in medical devices, while working within Quality is required. GMP experience working within ISO 13485 and FDA 21 CFR Part 820 environments. Capable of reviewing and interpreting drawings Experience in performing test method validation and Gage R&Rs is preferred In-depth understanding of statistical techniques such as normality analysis, tolerance analysis, and should be able to analyze and interpret data with high confidence. Must know how to use Minitab or other statistical software Strong analytical, planning and organizational skills Strong interpersonal and communications skills (oral & written) Self-starter with ability to work independently under pressure and react quickly to changing priorities Proficient in MS Office (Word, Excel, Power Point, Project, Visio)

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