5+ years experience with a Bachelor’s degree or 3-4 years with a Master’s degree in relevant field
Medical device industry experience is a must
Strong ability to work independently and take direction
Demonstrated experience in coordinating with contract manufacturers and internal teams
Proficiency in post-market surveillance report authoring and reviews
Experience in leading corrective and preventive actions (CAPA)
Skilled in root cause analysis for quality improvements
Responsibilities
Lead departmental and cross-functional engineering quality initiatives
Provide direction and mentoring for engineering and technical teams
Research, identify, and adopt advanced Quality Engineering practices
Mentor colleagues on resolving quality issues with technical guidance
Develop process control systems to ensure product quality
Implement assurance processes and CAPA systems to fulfill compliance requirements
Collaborate effectively as a leader or team member in quality-related practices
Utilize systematic problem-solving methods to tackle quality issues
Streamline business systems to detect and address quality issues
Benefits
Opportunities for professional development and training
Supportive and collaborative team environment
Involvement in cutting-edge medical device projects
Potential for impact on product quality and patient outcomes
Engagement with diverse cross-functional teams to enhance skill sets
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,
