Development Quality Engineer
828 Towne Center Drive Pomona California USA 91767 Pomona, CA 91767 US
This job description will be reviewed periodically and is subject to change by management.
- Act as quality assurance support for the design and development of In-Vitro Diagnostics (IVD) medical device products, facilitating the application of design/change controls, risk management, quality plan and implementation of design and development plan.
- Work closely with R&D, Manufacturing, Quality Control, and Applications Support management to prevent non-conformities and provide solutions to complex issues.
- Support multiple projects, balancing priorities and resources to meet project and management expectations.
- Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
- Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
- Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations.
- Perform failure mode analysis on new or existing products. Ensure all reasonable failure modes are identified. Working with peers, develop mitigations for failure modes, and verify the effectiveness of these mitigations.
- Coordinates for both new products/processes and changes to existing products/processes develop verification and validation plans that assess if requirements are met. Oversee the execution of verification and validation plans in conjunction with validation and process improvement engineers.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
- Carries out duties in compliance with established business policies.
- Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
- Perform other duties and projects as assigned.
MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:
- BS/BA degree in Engineering or field of science such as Chemistry, Microbiology, Biology, Biochemistry)
- Minimum of 2-5 years’ experience in a quality role within a highly regulated industry
- Minimum of 2 years hands-on risk management experience in developing and maintaining risk management files such as UMFMEA/DFMEA/PFMEA, Plans, Reports, etc.
- Minimum of 2 years of quality engineering experience (design controls/change control, process validation, on market engineering support and risk management) in a regulated environment.
- Experience reviewing and approving plans and reports for design verification, design validation, and process validations required.
- Experience reviewing and approving Device Master Record (DMR) documents required.
- Knowledge of Quality System Regulations.
- Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor.
- Must be detail-orientated, self-motivated and available for flexible scheduling.
- Direct work experience in IVD or medical device/biotech or regulated manufacturing environment.
- Experience acting as quality lead supporting new product development desired.
- Experience with design transfer of products from development to production desired.
- Hands on Design Verification, Design Validation, and Design History File (DHF) experience desired.
- Experience with chemistry related reagent, ELISA, HEIA manufacturing desired.
- Knowledge of IVDR in EU, FDA QSRs and ISO 13485:2016 standards.
- Goal oriented, learns quickly, works in a collaborative manner with other departments.
- Strong writing and verbal communication skills.
- Knowledge of computers and software programs including Word, Excel, Access, Visio, MS Project, Minitab, PowerPoint and Agile.
- Experience with root cause analysis, failure mode analysis, verification, and validation.
- Experience with process validations, design verification and design validation studies.
- Analytical Skills (e.g. statistical, risk analysis, engineering analysis)
- Team player
- Interpersonal Skills
- Drives for results
- High level of attention to detail
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.