Quality System Engineer III

Recruiter: Spencer Gregory Hale

Quality Systems Engineer III

About the Role:

The role of a Quality Systems Eng III is to develop, establish and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.  They will also serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals and priorities. In addition, will provide quality engineering support within technical development concepts, regulatory, operational, or system/services support.

Your Responsibilities will Include:

• Applies technical quality engineering principles to assigned projects, products or sites and guides them into implementation.
• Support internal audits as site representative according to defined scope and regulation.
• Ensure External Audit Readiness.
• Identify and mentor teams on applying Corrections and Corrective actions.
• Act as site Subject Matter Expert on Document Control, Records Control, and Training systems.
• Advocate for Preventive Quality culture.
• Provide project Quality direction, coaching, and mentoring for engineering and technical team personnel as appropriate.
• Investigates, identifies, and implements best-in-class Quality Engineering practices as requested by management.
• Identifies and implements effective process and design control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external quality and regulatory requirements.
• Lead the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Potentially act as team member in supporting quality disciplines, decisions, and practices.
• Apply effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Assure the development and execution of streamlined business systems, which effectively identify and resolve quality issues.
• Analyze Quality data for local or franchise management reporting (CAPA Review Board, Quality Management Review. Document Control activities), and advise management on potential improvements or enhancement to quality systems and processes in the company. 
• Manage R&D tooling and equipment program including maintenance and calibration activities.
• Support site infrastructure needs including EH&S, pest control, and cleaning activities.

Required Qualifications:

• Bachelor’s degree in engineering AND 4+ years of professional experience in med device, healthcare, or a regulated industry (or 10+ years of engineering experience in the med device or healthcare industry if no degree)
• Experience with audits and document/records control
• Experience with manufacturing process controls and/or distribution
• Experience with 21 CFR Part 820, ISO 13485, AIMDD, MDD, MHLW, MDR SOR/98-282, 21 CFR Part 211, ISO 14971, Therapeutic Goods Regulations 2002, Resolution RDC No 16 or March 28, 2013, 21 CFR Part 4
• Ability to understand and evaluate procedural documents to ensure compliance in all applicable regulations and requirements
• Strong organizational skills with ability to multi-task and prioritize competing responsibilities in a fast-paced environment
• Customer service-oriented with ability to communicate effectively (written and verbally) with individuals on all levels
• Ability to work independently and collaborate with internal teams - leadership skills are essential
• Strong problem-solving and critical thinking skills; analytical, process and results-oriented

Preferred Qualifications:

• ASQ certification
• Experience with R&D teams
• Experience with calibration activities
• Project management experience

 Requisition ID: 595568

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran’s status, age, mental or physical disability, genetic information or any other protected class.