Astute Medical, Inc.
3550 General Atomics Ct, Building 2, San Diego, CA 92121
Senior Quality Assurance Engineer
General Job Description:
Astute Medical, Inc. is seeking a Senior Quality Engineer who will be responsible for ensuring Astute Medical establishes and maintains compliance to ISO13485, ISO14971, 21CFR Part 820, the IVDD, the IVDR and other applicable regulations and standards. Emphasis is placed on strong understanding and experience with applicable ISO/EN standards, FDA, QSR, and European IVDD/IVDR as well as experience with ISO and/or FDA audits.
Responsible for ensuring compliance with applicable Astute Medical policies and procedures across the organization.
Refine Quality System procedures and processes based on knowledge of regulations and business needs as well as output from the CAPA system.
Assess Quality System for impact of new standards including IVDR.
Facilitate cross-functional team meetings for collaboration on design change plans, risk management, manufacturing change requests, and internal audit findings.
Lead and facilitate FMEA meetings with applicable functional areas to assess and update risk documents for process changes, design changes, complaints, CAPA, etc. Write risk reports and conduct post-market surveillance on product lines in compliance with current requirements for ISO14971.
Establish statistically based sampling plans for variable and attribute data for validations, CAPAs and contract manufacturing testing. Mentor and provide guidance to others on statistical based plans.
QA lead in validation strategy meetings (software, equipment, and process). Advise team on required acceptance criteria, develop statistically based sampling plans. QA lead on discrepancy resolution. Review and approve validations.
Conduct all aspects of supplier and internal audits. Develop and write audit plans, conduct audit, write audit reports. Collaborate with audit team and auditees on findings and corrective actions.
Facilitate continuous improvement of the CAPA system including CAPA metrics. Lead and provide direction on investigations and corrective/preventive actions related to issues received through CAPA, post market surveillance, and product support as required to determine deficiencies in the quality system, product and manufacturing processes.
Quality lead for NephroCheck Test System. Review Design Change Plans for assessment of impact to areas of Design Control (e.g., Design Input Requirements, verification, validation, requirement outputs). Lead bi-weekly design change meetings. Ensure Design Change are compliant with internal and external regulations. Responsible for ensuring all DHF documentation is present and maintained.
Mentor other members of Quality team and cross-functional teams.
Performs other duties & projects as assigned.
Identifies and addresses all complexities of compliance issues
BS/BA (or higher) degree in science/technical discipline or equivalent.
5+ years related experience or equivalent.
Strong emphasis placed on working with technical disciplines and understanding of product technologies and associated processes.
Strong experience with federal, 3rd party agencies or regulatory agencies, e.g., 21 CFR Part 820, ISO14971, ISO 13485, IVDD and IVDR.
Knowledge and application of statistical techniques.
Ability to work on multidisciplinary teams.
Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks.
Problem-solving and troubleshooting skills.
Strong verbal and written communication skills.
Demonstrates time management, decision making, presentation, and organization skills required.
Proficient with Microsoft Office and Visio.
Willing and able to travel as required (~10-25%)
Application Information & Contact (How to Apply)
Please apply through their career page here.
Learn more about Astute Medical here.