Senior Quality Engineer

About the role:
Develops, establishes, and maintains quality engineering methodologies, systems, and practices that meet company, customer, and regulatory requirements.   Serves as a Quality representative to improve awareness, visibility, and 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.

Job Responsibilities will include:

• Provides a leadership role in 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 ongoing 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 that effectively identify and resolve quality issues.

Required Qualifications:

• Bachelor’s degree in Biomedical Engineering or related engineering discipline
• 5+ years of technical experience in the medical device or pharmaceutical industry
• Validation experience
• Knowledge of risk management concepts, a proven track record of developing, implementing, and execution
• Internal/External audit experience
• 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