Sr. Quality Engineer
Position: Sr. Quality Engineer
Location: Costa Mesa
Posted: August 30, 2021
AccuMedical USA Inc. is looking for a Sr. Quality Engineer to join our innovative and dynamic team in Costa Mesa, California.
AccuMedical is focused on developing innovative therapies for neurovascular products that will address global, unmet medical conditions and patient needs. As a thriving small company with a multinational team, we work in a fast-paced international environment, empowering our team members to take initiative, make decisions and lead with opportunities to excel and grow in their expert fields. We foster a work/life balance with the dedication to the wellness of our employees.
Essential Responsibilities of the Sr. Quality Engineer include:
- Lead or engage in New Product Integration (NPI) projects including quality planning, manufacturing processes, procedures and process flow to transfer into a large-scale, lean manufacturing (design for manufacturing) with considerations for future sustaining activities and lifecycle management
- Perform or provide support in reviewing of new or updated ISO/IEC standards and conducting impact analysis of products/processes
- Participate as a Quality representative in the cross-functional new product development team and work closely with R&D Engineers to provide guidance/support in establishing design control documents, risk management documents and quality plans to ensure continued compliance with internal QMS and regulatory requirements
- Develop and implement design improvements from design freeze throughout large scale manufacturing
- Perform or participate in qualifying/disqualifying and monitoring of suppliers to comply with the company’s Product Quality Process (PQP) and perform supplier risk evaluation
- Establish and manage Device Master Record (DMR) including BOM, SOPs, Work Instructions, product specification/drawing, etc.
- Perform or support lifecycle equipment management from installation to decommission as well as conducting validation
- Provide technical solutions for product development issues such as design, process, materials, test methods by identifying and ensuring the optimizing of R&D processes and manufacturing processes using engineering methodical approaches
- Conduct investigations of complex design and manufacturing product quality compliance issues as well as supplier issues through CAPA and NCR and participate in MRB reviews.
Education and Experience:
- Must be eligible to work in the U.S. and not require visa sponsorship
- Bachelor’s Degree in Engineering or another Scientific discipline with a minimum of 7 years of experience or Master’s Degree in Engineering or another Scientific discipline with a minimum of 5 years of experience.
- Working knowledge of Medical Device regulations for FDA 21 CFR 820 (QSR).
- Working knowledge of international Medical Device regulations preferred.
- Proficient in ISO standards (ISO 9001, ISO 13485, ISO 14975, ISO/TR 24971/2020)
- Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
- Working knowledge and understanding of statistical techniques
- Strong technical writing, documentation, communication and interpersonal relationship skills
- Six Sigma Green/Black belt preferred
To apply online (Indeed) click the link: