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, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support.
Functional Engineering Roles include: Design Assurance, Operations Quality, Software Engineering, Supplier Assurance, Product Analysis, Metrology, Microbiologist, Chemist
Key Responsibilities
1. Provides leadership role on championing departmental or cross-functional engineering initiatives.
2. Provides project direction, coaching, and mentoring for engineering and technical team personnel.
3. Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
4. Mentor for technical guidance for identifying and resolving quality issues.
5. Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
6. Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
7. Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
8. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
9. Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.
Quality Systems Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Qualifications
5+Years with BS, 3 -4 Years with MS
Ability to take work direction and work independently
Medical device experience
Primary work assignments will be involving supporting our Quality systems and Quality operations for our hepatic artery infusion pump and accessories– authoring post market surveillance report, periodic document reviews, CAPA coordination and ownership, communicating with the contract manufacturer and BSC Quality/operations/design teams, supporting design changes activities and supplier corrective records, etc.
Post market surveillance experience
Experience owning CAPA
Root cause analysis experience
Preferred:
someone with 5+ years of experience in medical device
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