5+ years of experience with a Bachelor's degree or 3-4 years with a Master's degree in a relevant field.
Experience in the medical device industry.
Strong root cause analysis skills.
Proven ability to work independently and follow direction.
Experience in coordinating quality activities with contract manufacturers.
Responsibilities
Champion departmental and cross-functional engineering initiatives.
Direct projects and mentor engineering personnel.
Investigate and implement best-in-class Quality Engineering practices.
Provide technical guidance in resolving quality issues.
Implement effective process control systems for product development.
Lead the establishment of CAPA systems to meet compliance requirements.
Actively support quality decisions and practices within teams.
Benefits
Opportunity for professional development and growth.
Exposure to innovative quality engineering methodologies.
Involvement in high-impact product quality initiatives.
Collaboration with various engineering disciplines and teams.
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,
