Insight Global is targeting two Senior Quality Engineers to join a medical device manufacturing client local to Bedford, MA, 01730.

Location: Bedford, MA, 01730

Permanent Job Opportunity, no contact

Fully Onsite, potential for 1 day remote weekly over time

Pay: $115,000-$145,000

• Pay is determined by multiple factors including candidate experience

Required Skills & Experience

• Bachelor's degree in engineering or science (or equivalent)
• Minimum 6-8 years in medical devices, pharmaceuticals, diagnostics, or clinical labs; or 5 years with an advanced degree
• Regulated industry background: Medical Device, Automotive, or Aerospace industry
• Broad knowledge of engineering and science principles, including R&D, quality control, manufacturing, and design engineering
• Experience with CAPAs
• Quality Management Techniques: Lean Six Sigma, Statistical methods to measure changes
• Product Knowledge: IL products, technology, and manufacturing processes, Impact on customers and patients
• Regulatory Compliance: Application of regulatory requirements to data review, reports, design changes, risk management
• Risk-based approach to processes and decisions

Nice to Have Skills & Experience

• Medical Device Regulated industry Experience
• Certifications: ASQ Quality Engineering, LEAN/Six Sigma
• Stats, programming, data visualization

Job Description

This position ensures product lifecycle activities comply with relevant procedures, standards, and regulations.

Key responsibilities include:

• Generating and reviewing quality documents
• Advising teams on compliance and implementing procedural changes
• Ensuring product quality and documentation completeness
• Supporting new product development and design changes
• Defending quality topics in audits and corrective actions
• Leading design control and product realization for significant projects
• Guiding on tools and techniques for product development and investigations
• Providing input on product requirements and evaluations
• Applying statistical methods and quality tools
• Ensuring software compliance with standards, including cybersecurity
• Collaborating with various departments to recommend or prepare corrective/preventive actions (CAPA)