Quality Manager - Engineering Astute Medical, Inc.
THIS JOB HAS EXPIRED Job ID#: 55103
Astute Medical, Inc. is an early stage diagnostics company dedicated to improving the diagnosis of high-risk medical conditions through the identification and validation of protein biomarkers that can serve as the basis for novel in vitro diagnostic tests.
Astute Medical, Inc. is seeking a motivated self-starter who will lead quality compliance within the engineering group which is responsible for development of equipment, instrumentation and software utilized in the manufacture and use of Astute Medical products. This position will be responsible for ensuring the engineering group establishes and maintains compliance to ISO13485 & 21CFR Part820. The individual will work closely with QA to develop and implement quality systems related to the engineering group, such as design control, software validation, and equipment OQ/PQ/IQ.
Emphasis placed on:
Understanding of applying ISO/EN standards, FDA, QSR, and European IVDD to engineering design and development inputs and outputs;
Ability to technically understand manufacturing equipment and software;
Strong verbal and written communication skills
1. Responsible for compliance with applicable Astute Medical policies and procedures.
2. Work with Engineering and Quality depts.to set strategic direction for Quality Systems such as design control, risk management, adequacy of testing and process and production control systems as they relate to engineering.
3. Coordinate and assume lead role in validation planning and establishment of testing criteria for equipment, and software validations based upon FMEA outcome, knowledge of the product, process, and regulations. Lead and facilitate validation strategy meetings. Write and review validation documentation.
4. Act as Quality Assurance/Compliance representative within the Engineering department as well as liaison between Quality Assurance and Engineering to ensure cross-functional alignment.
5. Assist other members of the engineering team with understanding the Quality System requirements.
6. Engineering representative on Design Control teams ensuring documentation such as customer needs, design input requirements, and design and development plans are adequate, accurate, and in compliance with internal and external regulations. Responsible for ensuring applicable DHF documentation is present and maintained.
7. Using technical and compliance knowledge author Design Change documentation and assume ownership for leading activities required to realize the change.
8. Review DHF documentation from Contract Manufacturer to ensure adequacy and compliance. Provide feedback to Contract Manufacturer as well as Astute Engineering and Quality Assurance.
9. Author software validation documentation including but not limited to Requirement Specification, Protocols, Reports, Trace Matrices, Risk Assessment, and Deviations. Work with Engineering to author Design/Architecture Document. Ensure all requirements are traceability to specifications and test cases as appropriate.
10. Based upon knowledge of product, processes, and regulations, develop and document risk management plans, hazard IDs, risk analysis (FMEA), risk reports and conduct post-market surveillance on product lines in compliance with current requirements for EN ISO14971.
11. Provide direction on investigations related to significant issues received through CAPA, post market surveillance, and product support as required to determine deficiencies in product and manufacturing processes.
12. Develop and implement Quality System procedure and processes in preparation for ISO certification and FDA compliance. Procedures and processes are to be based on knowledge of regulations and business needs.
13. Provides guidance to less experienced staff; acts as a mentor to lower level individual contributors.
14. Performs other duties & projects as assigned.
Preferred educational background:
BS/BA degree in science or technical discipline or higher.
7+ years related experience.
Strong emphasis placed on working with technical disciplines and understanding of product and process technologies
Experience with federal, 3rd party agencies or regulatory agencies, e.g. 812 QSR?s, ISO, ISO 13485, CMDR) and statistical sampling plans.
Ability to work on multidisciplinary teams.
Identifies and addresses all complexities of compliance issues
Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks
Demonstrates 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.
Prior experience in a fast-paced, entrepreneurial environment is a plus
||San Diego, CA |
THIS JOB HAS EXPIRED