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Senior Quality Engineer, Product Quality Complaints

3 months ago

Brockton, Massachusetts, United States Insmed Incorporated Full time

Join Insmed, a leading biopharmaceutical company focused on improving the lives of patients with serious and rare diseases.

Insmed is committed to building a collaborative and inclusive work environment where employees are empowered to make a difference. Our team, guided by core values of collaboration, accountability, passion, respect, and integrity, is dedicated to driving innovation and delivering top-quality solutions for patients worldwide.

Recognitions:

  • Named Sciences Top Employer multiple times
  • Great Place to Work-certified for three consecutive years

Join us as a Senior Quality Engineer at Insmed

As a Senior Quality Engineer at Insmed, you will play a key role in ensuring product quality and customer satisfaction. Reporting to the Director of Product Quality Complaints, you will be responsible for managing QA Compliance activities, conducting product complaint investigations, and maintaining SOPs to meet regulatory standards.

Responsibilities:

  • Manage Deviation/CAPA/EC and product quality complaint investigations
  • Ensure compliance and continuous improvement within QMS
  • Handle compilation of Product Quality Complaints metrics for monthly trending
  • Provide training to internal and external stakeholders
  • Assist in inspection readiness activities and audits
  • Investigate complex deviations and identify trends of quality events

Job Requirements:

  • Minimum of 5 years of relevant Quality Assurance experience in Engineering, Life Science, or related field
  • Experience with product quality complaints in a regulated industry
  • Knowledge of cGMP's and Good Documentation Practices
  • Strong organizational and communication skills

Travel Requirements: Flexible

Salary Range: $88,000.00 to $122,467.00 per year

Compensation & Benefits:

  • Flexible work options
  • Competitive compensation package
  • Stock options and 401(k) plan
  • Comprehensive health and wellness benefits

Additional Information:

Insmed is an Equal Opportunity employer. We value diversity and do not accept unsolicited resumes from agencies.

Applications accepted until position is filled.