5+ years of experience with a BS or 3-4 years with an MS in a related field
Experience in the medical device industry
Ability to work independently and take work direction
Expertise in coordinating between contract manufacturers and design teams
Experience with post-market surveillance and periodic document reviews
Proven ability to own CAPA processes
Strong background in root cause analysis
Responsibilities
Lead and champion quality engineering initiatives across departments
Provide project direction and mentorship to engineering teams
Investigate and implement best-in-class Quality Engineering practices
Offer technical guidance for resolving quality issues
Establish effective process control systems for product development and manufacturing
Lead implementation of process controls and CAPA systems
Act as an effective leader in supporting quality disciplines
Apply systematic problem-solving strategies to address quality issues
Ensure development of streamlined business systems for quality issue resolution
Benefits
Opportunity to impact quality engineering practices
Mentorship and professional development opportunities
Involvement in innovative medical device projects
Collaborative work environment with cross-functional teams
Engagement in regulatory compliance and quality assurance initiatives
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,
