5+ years in Quality Engineering with a BS, or 3-4 years with an MS
Experience in the medical device industry
Strong communication skills for cross-functional collaboration
Experience with CAPA (Corrective and Preventive Action) processes
Familiarity with post-market surveillance and regulatory compliance
Proven ability to work independently and take direction
Responsibilities
Lead and champion quality engineering initiatives across departments
Direct projects and mentor engineering teams in best practices
Identify and implement cutting-edge quality engineering practices
Provide technical guidance for resolving quality issues
Develop and implement effective process control systems
Oversee the establishment of CAPA systems to meet regulatory requirements
Utilize systematic problem-solving methods to address quality issues
Benefits
BSC's focus on quality and regulatory compliance training
Opportunities for professional development and mentorship
Collaborative team environment with cross-functional exposure
Involvement in innovative projects related to cutting-edge medical devices
Potential impact on product quality and patient safety through direct involvement
Full Job Description
Summary:
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.
Provides leadership role on championing departmental or cross-functional engineering initiatives.
Provides project direction, coaching, and mentoring for engineering and technical team personnel.
Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
Mentor for technical guidance for identifying and resolving quality issues.
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.
Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
cts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
pplies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
ssures the development and execution of streamlined business systems which effectively identify and resolve quality issues.
Requirements :
5+Years with BS, 3 -4 Years with MS
bility to take work direction and work independently
Medical device experience
coordination and ownership, communicating with the contract manufacturer and BSC Quality/operations/design teams, supporting design changes activities and supplier corrective records, etc. CAPAPrimary 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,
