Job Description:

• ASQ Certified Quality Engineer or CQA Certified Quality Auditor.
• Demonstrated knowledge of Quality Management System tools and continuous improvement methodologies.
• Demonstrated supply quality experience within the medical device industry.
• 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.

Functional Engineering Roles include:

• Design Assurance, Operations Quality, Software Engineering, Supplier Assurance, Product Analysis, Metrology, Microbiologist, Chemist.

Responsibilities:

• Identify and implement effective process control systems to support the development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements.
• Lead 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.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Assure the development and execution of streamlined business systems that effectively identify and resolve quality issues.
• Improve supplier quality performance for assigned suppliers via Part Quality Plan (PQP) implementation. Communicate, clarify and facilitate supplier Part Quality Plan (PQP) submissions, as well as conduct PQP review and approval for purchased products.
• Approve supplier selection through robust qualification processes, including supplier audits.
• Assure supplier compliance with Quality Management System (QMS) and regulatory requirements.
• Assure Corrective and Preventive Action (CAPA) plans are developed and executed at assigned suppliers in compliance with the CAPA process.

Requirements:

• Bachelor’s degree - 3-5 years of experience.
• Bachelor’s Degree in an engineering or technical discipline (or non-technical degree with 7 years of experience in manufacturing, engineering or quality assurance.
• Minimum 5 years’ experience in manufacturing, engineering design, quality assurance or regulatory assurance.
• Effective problem-solving, root cause analytical skills to lead and influence others to drive change.

Functional Engineering Roles include:

• Design Assurance, Operations Quality, Software Engineering, Supplier Assurance, Product Analysis, Metrology, Microbiologist, Chemist

Responsibilities:

• Identify and implement effective process control systems to support the development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements.
• Lead 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.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Assure the development and execution of streamlined business systems that effectively identify and resolve quality issues.
• Improve supplier quality performance for assigned suppliers via Part Quality Plan (PQP) implementation. Communicate, clarify and facilitate supplier Part Quality Plan (PQP) submissions, as well as conduct PQP review and approval for purchased products.
• Approve supplier selection through robust qualification processes, including supplier audits.
• Assure supplier compliance with Quality Management System (QMS) and regulatory requirements.
• Assure Corrective and Preventive Action (CAPA) plans are developed and executed at assigned suppliers in compliance with the CAPA process