Astute Medical is seeking an energetic, self-motivated individual who can fill the role of Office Manager to support the commercialization of its novel biomarker products.
JOB TITLE: Senior Quality Assurance Engineer
DEPARTMENT: Quality Assurance
REPORTS TO: Senior Director, Quality Assurance
Astute Medical, Inc. is an in-vitro 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. To support the life-cycle of its novel biomarker products, Astute Medical is seeking an energetic, self-motivated individual who can fill the role of Senior Quality Engineer.
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.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- 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%)
While performing the duties the employee is:
- Constantly required to reach computers and other office and laboratory equipment
- Constantly required to view objects at close and distant ranges
- Frequently required to communicate with others
- Frequently required to sit
- Frequently required to use fine manipulation and simple grasping in order to handle laboratory equipment and to utilize the computer and other standard office equipment such as telephone, fax machines, copiers, etc.
- May occasionally be required to travel to meetings and tradeshows
Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.
Employee frequently works in an office environment with a moderate amount of noise and activity. The work environment is fast-paced and demanding. Work weeks exceeding 40 hours are required as necessary
Primary Location: AMER-AMER-US-CA-San Diego, CA
Job Posting: Apr 8, 2019, 4:59:51 PM
Shift: Day Job
Employee Status: Regular
Travel: Yes, 10% of the time