Design Quality Assurance Engineer II - Endoscopy
About The Position
The Design Quality Assurance Engineer II directly supports medical device product development from concept through commercialization. This individual will work with a high-performance cross-functional team to ensure the safety, quality, and compliance of our Endoscopy products. Provides quality engineering support as part of a new product development or sustaining team. Develops, establishes, and maintains quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals, and priorities.
Requirements
- Minimum of a bachelor’s degree in engineering
- Minimum of three years of experience in design assurance, new product development, or related medical device experience
- Ability to travel up to 15% (international and domestic)
- Ability to be onsite for a minimum of 3 days per week
Nice To Haves
- Master’s degree in engineering
- ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
- Demonstrated experience using Quality tools and methodologies
- Experienced in cross-functional collaboration and facilitating problem-solving
- Experience with design changes, complaint reduction, and corrective actions
- Strong communication (oral and written) and presentation skills.
Responsibilities
- Working knowledge of Design Controls. Provide quality and compliance input to project teams for project decisions and deliverables (i.e. Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, and Labeling).
- Creation and review of Risk Management documentation such as Hazard Analysis, Task Analysis, Design Failure Mode and Effects Analysis (DFMEA) and Fault Tree Analysis (FTA). Understand and support linkage of field data and Risk Management.
- Apply sound, systematic problem-solving methodologies to resolve quality issues.
- Champion compliance to company policies, work instructions and SOPs.
- Support Post Market activities such as assessment of risk based on post-market signals, field assessments
- Support effective quality assurance, process controls and metrics using data and statistical analysis to drive improvements.
- Lead the implementation of NCEP’s and CAPA’s while meeting or exceeding internal and external requirements
- Support internal and external regulatory audits as required.
Benefits
- Relocation assistance may be available for this position at this time.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
