Our client is seeking Senior Quality Engineer to provide support for projects such as review and approval of design/process/supplier changes and maintenance of Risk Management / Design History files. The Quality Engineer is responsible for facilitating compliance to applicable internal and external requirements for commercial products.
Responsibilities
- Ability to design and execute validation protocols (IQ/OQ/PQ) for manufacturing processes and product testing, as well as experience in verification testing to ensure product compliance with regulations.
- Knowledge of design control and the ability to collaborate with the Design and Development Team to ensure that product development meets quality and regulatory standards.
- Strong analytical skills to interpret data, identify trends, and address quality issues.
- Precision in reviewing documentation, test results, and reports to ensure compliance with strict quality standards.
- Collaborate with Design teams, provide technical support, and facilitate the successful execution of the Design Changes for mechanical surgical devices.
- Support Design Verification and Validation activities, including review of verification & validation protocols and reports.
- Actively participate in cross-functional team meetings to understand the impact of changes to product performance and the associated documentation required.
- Provide subject matter expertise and input in the following areas: design inputs / outputs, biocompatibility, cybersecurity, reliability, usability, shelf-life studies, and cleaning validation.
- Interface with all departments to provide leadership on the use of Quality Engineering methodologies, tools, and regulatory compliance requirements.
- Ensure that technical information is accurate and complies with quality and regulatory requirements.
- Review Design Changes pre and post-design transfer.
- Maintain and manage site risk files in accordance with ISO 14791 and other applicable standards. Work cross-functionally with the Subject Matter Experts from R&D, Clinical, and Operations to ensure a comprehensive risk management files post-design transfer.
- Gather information from various sources to conduct periodic risk reviews.
- Ensure new risks from any design / process changes are captured in the Risk Management Files.
- Revise risk files as needed to comply with the latest procedures and risk scales.
- Implement Design Control/Risk Management process improvements to ensure a more effective, efficient, and compliant processes.
- Review and support the DHF.
- Ensure that technical information is accurate and in compliance with international regulatory requirements.
- Perform all duties with minimal oversight required from direct manager.
- Additional responsibilities include: generating and revising relevant procedures, preparing and analyzing quality trend data, supporting the resolution of CAPAs to closure and verification of effectiveness, and participation in internal and external audits.
Qualifications
- Bachelor of Science degree in technical discipline - Mechanical Engineering or Biomedical Engineering is preferred.
- Prior experience with implants or instruments products required.
- Minimum of 2-3 years of quality engineering or related experience in an FDA regulated medical device environment.
- Proficiency with medical device development life cycles and Design Control processes (at least 3 years; 5+ years preferred).
- Ability to handle complex issues and exercise judgment, based on experience, with minimal oversight from the manager.
- Knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971.
- Knowledge of IEC 62304, IEC 62366, IEC 60601, Biocompatibility, and Aging Studies preferred.
- Understanding of Medical Device software requirements preferred but not required.
- Ability to write Verification / Validation protocols and reports.
- Problem solver.
- Six sigma green belt and/or ASQ CQE preferred.
- Competent using office software including MS Word, Excel, PowerPoint, and Outlook.
- Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally with internal and external partners and regulatory bodies.
- Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to apply sampling plans and statistical methods for data analysis.
- Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings.
Location
Employee Type
About Ventura Solutions
Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled