Quality Engineer II

About the role:
The Quality Engineer II serves as a quality representative who improves awareness, visibility, and the communication of quality initiatives in support of functional, departmental, site, divisional, and corporate quality goals, and priorities.  This role is responsible for providing quality-based input to support manufacturing, operations, and distribution activities while leveraging extensive technical knowledge and experience across multiple product and production platforms.  The incumbent will develop, establish, and maintain quality engineering methodologies, systems, and practices to meet company, customer, and regulatory requirements.
Responsibilities will include:

• Supporting specific production areas in achieving required quality standards; and providing guidance to quality inspectors and technicians as needed.
• Leading and supporting cross-functional teams in identifying root causes and implementing corrective and preventative actions (CAPA) to control and reduce manufacturing process defects (scrap, nonconforming material, customer complaints); may be responsible for creating risk analyses and FMEAs.
• Initiating and leading nonconforming events and CAPA projects; supporting internal and external regulatory audits.
• Collecting and analyzing process defect data to support product and process improvement efforts; applying problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Gathering and analyzing quality metric data to enhance sustaining product design and new product development; support site and divisional projects to ensure product introductions, processes, and related changes meet regulatory requirements.
• Assessing design and process changes to determine the impact on patient care and compliance with quality system requirements; own risk management documentation for assigned processes.
• Leading continuous improvement projects and identifying best practices.

Required Qualifications:

• Bachelor’s degree in Biomedical Engineering or related engineering discipline
• 3+ years of technical experience in the medical device or pharmaceutical industry
• Working knowledge of FDA QSR (21 CFR Part 820) and ISO 13485 with the ability to understand other medical device regulations and standards.
• Experience with nonconforming material, CAPA methodologies, and related systems
• Experience working in cross-functional teams and driving projects to completion

Preferred Qualifications:

• Certified Six Sigma Green Belt (CSSGB)
• ASQ Certified Quality Engineer (CQE) or Biomedical Auditor (CBA)
• Project management experience with strong presentation and facilitation skills
• Working knowledge of analytical techniques and statistical analysis
• Proficient with Microsoft Office Suite and Minitab Statistical Analysis software (or equivalent)
• Ability to work independently and collaborate with cross-functional teams to complete projects.
• Strong interpersonal skills, with the ability to communicate effectively with individuals on all levels.
• Strong critical thinking and analytical skills: process and results-oriented
• Detail-oriented with strong organizational skills; ability to multi-task and prioritize competing responsibilities effectively.