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Senior Quality Engineer, Product Quality Complaints

2 months ago

Bridgewater, United States Insmed Incorporated Full time

Company Description

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. 

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. 

Recognitions

Named Science's Top Employer in 2021, 2022, and 2023

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for two years in a row.  

 

 

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.  

 

Overview The Senior Quality Engineer at Insmed position reports directly to the Director of Product Quality Complaints. The primary responsibilities include managing QA Compliance activities, including technical writing of Deviations/CAPA/EC documents. Monthly/Quarterly Metrics reporting, SOP updates, and conducting product complaint investigations, including communication with patients for troubleshooting support. Additionally, the role includes tasks related to audit support, training, and diligent tracking of complaint data. Overall, this position plays a critical role in ensuring product quality and customer satisfaction within the organization.

Responsibilities

The Senior Quality Engineer is responsible for managing Deviation/CAPA/EC and product quality complaint investigations within QMS, ensuring compliance, continuous improvement, and day to day operations.   Thorough investigations are conducted on assigned complaints to ensure completeness, accuracy, and regulatory compliance, including batch reviews, identify root causes, replacement product needs, responds to patients, and ensures adverse events are promptly reported within 24 hours to the appropriate department per applicable regulations.Handles compilation of Product Quality Complaints metrics for monthly trending, management review meetings and process improvement closure, presenting and communicating trending reports in Quality Forums.Receives cross training on all PQC process (intake, patient/customer follow up, investigations,) and act as QA owner as required.Provides product and complaint training to internal and external stakeholders. SOPs, policies, and standards are regularly reviewed and updated to comply with GxP standards, FDA/EMA/ICH and other competent authority regulations.Identify opportunities for process improvement projects to drive success in product quality complaints and device support processes and shares best practices with the Patient Support & Quality teams.Assists in inspection readiness activities and plays a key role during inspections/audits.Provides support during internal review, Audits, FDA Audits and Third-party AuditsComplex deviations are investigated with thorough root cause analysis, documented with corrective actions for prevention of reoccurrence. Tracks and identifies trends of quality events, including Complaints/Deviation/CAPA/EC.Serves as a technical product expert and assist patients with trouble shooting their complaints.Job Requirements:Minimum of 5 years of relevant Quality Assurance experience in Engineering, Life Science, or related discipline with a BS Degree. An advanced degree (MS) and a minimum of 3 years relevant experience will also be considered.Preferred ASQ CQE certification and/or Root Cause Analysis CertificationExperience with product quality complaints in regulated industry.Direct involvement in Document Control, and Deviations/CAPAs, in pharmaceutical or medical device industryThorough knowledge of relevant cGMP's and Good Documentation PracticesPreferred experience with Veeva Vault Quality Management SystemFamiliarity of pharmaceutical product manufacturing processes and medical deviceExcellent verbal and written communication skillsProven capability to manage projects and variable workloads.Strong organizational skills with a keen focus on detail, clarity, accuracy, and conciseness. Proficient in Microsoft Office tools such as Word, Excel, PowerPoint, Outlook, or Minitab.Demonstrated alignment with Insmed's core values: Collaboration, Accountability, Passion, Respect, Integrity. Ability to thrive in a dynamic and culturally diverse workplace.

Travel Requirements

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Salary Range Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees.

The base salary range for this job is from $88,000.00 to $122,467.00 per year

Compensation & Benefits

We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including: 

Flexible approach to where and how we work Competitive compensation package including bonus.  Stock options and RSU awards Employee stock purchase plan 401(k) plan with company match Professional Judgment Vacation Policy 11 paid holidays per year and Winter Break (typically between Christmas and New Year's Day). 

  

ADDITIONAL U.S. BENEFITS: 

Medical, dental, and vision plans Company-provided short- and long-term disability plans Company-provided life insurance Unique offerings of pet, legal, and supplemental life insurance Flexible spending accounts for medical and dependent care Accident and Hospital Indemnity plans Supplemental AD&D Employee Assistance Program (EAP) Mental Health on-line digital resource On-site, no-cost fitness center at our U.S. headquarters Paid time off to volunteer 

Additional Information

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. 

  

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. 

  

Applications are accepted until the position is filled.