5+ years of experience with a Bachelor's degree or 3-4 years with a Master's degree in a related field
Demonstrated ability to work independently and follow directed tasks
Experience in the medical device industry
Strong coordination skills with contract manufacturers and internal teams
Experience with Corrective and Preventive Actions (CAPA)
Proficient in root cause analysis and resolution of quality issues
Responsibilities
Lead cross-functional engineering initiatives and quality improvement efforts
Coach and mentor engineering and technical team members
Investigate and implement leading Quality Engineering practices
Provide technical guidance on identifying and resolving quality issues
Develop effective process control systems for product development and manufacturing
Implement CAPA systems to meet quality standards
Apply systematic problem-solving methodologies to manage quality challenges
Create streamlined business systems for effective quality issue resolution
Benefits
Comprehensive health benefits
Opportunities for professional development and mentorship
Engagement in cross-functional team initiatives
Visibility and communication on quality improvement projects
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.
Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Assures 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
Ability 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,
