Pharm Manufacturing- Sr Quality Engineer- Burlington, Ma

Michael Page

  • Burlington, MA
  • $115,000-130,000 per year
  • Permanent
  • Full-time
  • 1 month ago
  • Apply easily
Your role as a Quality ambassador in the Specialty Products division is centered on boosting awareness, visibility, and communication regarding quality, with a particular focus on aligning these efforts with the division's unique needs and objectives.
  • Develop and update risk management files for new processes and changes.
  • Assist in validations for new and existing products, processes, and equipment.
  • Lead NC/CAPA teams by creating corrective action plans and overseeing closure.
  • Coordinate supplier quality management, including qualification and investigations.
  • Manage batch record review and product disposition.
  • Prepare for and support site-level audits.
  • Apply problem-solving methods to resolve quality issues.
  • Identify and implement continuous improvement opportunities.
  • Collaborate with departments, vendors, and customers.
  • Perform other Quality System duties as needed
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.Serve as a Quality Representative to improve initiatives |Work on Multiple Products to serve Loyal Customers
  • 6+ years of experience in medical device
  • Experience in an FDA regulated manufacturing or industrial environment.
  • ISO 13485 Quality System
  • Technical skills and experience related to process validation, statistical methods, and risk management.
  • Six Sigma
  • Can work in person
We are a prominent global company in health, committed to safeguarding and improving the lives for millions worldwide-throughout every life stage. Our brand is rooted in the deep trust and allegiance of our customers, cultivated over our 170-year heritage. With a global workforce engaged in research, development, manufacturing, and commercial activities, we maintain a significant presence, connecting with billions of potential customers worldwide.competitive compensation package, room for growth, amazing team!

Michael Page