Werfen North America · 1 day ago
QA Manager I
Bedford, MA
Full-time
Onsite
Senior Level, Lead/Staff
$140K/yr - $160K/yr
10+ years expWerfen North America is a growing, family-owned, innovative company specializing in diagnostics. The QA Manager I is responsible for overseeing the complaint team, ensuring timely case review and complaint investigations, and managing the escalation process for potentially reportable complaints.
Health CareManufacturing
Responsibilities
Manages the complaint team to ensure accuracy and timely risk review and thorough complaint investigations are completed
Responsible for product family specific systems and documentation which contribute to an effective complaint system compliant with FDA, ISO and Worldwide standards. Ensures timely and thorough review of all com plaints and inquiries, prioritizing potentially reportable events
Escalate any potentially reportable complaint or inquiry, communicates with the cross functional team and management, drives the post market Risk Analysis Worksheet (RAW) process through completion
Communicates updates on escalations, priorities, and complaint status to leadership and in various meetings
Chairing meetings and providing guidance and direction to the RAW team
Trains and develops subordinates, as appropriate, to achieve duties and responsibilities
Coordinates and monthly complaint trend review meetings with appropriate departments and ensures that escalations, investigations and CAPA Actions are taken to remediate negative trends or for specific customer complaint issues, determination and resolution of root causes for complaints
Provide complaint inputs to the post market surveillance reporting process
Responsible for maintaining Complaint KPI data and reporting as necessary
Responsible for gathering complaint and RAW data for Post Market Surveillance and updating the RA reports including assessing newly identified risks
Follows regulatory requirements for complaint management
Establish and maintain a system to review literature and social media for complaints
Manages tasks supporting complaint investigations, Including returned parts and external assignments
Supports investigation activities and provides guidance for resolving product malfunctions
Performs other related duties as assigned
Qualification
Required
Bachelor's degree in relevant field (i.e. Life Science, Biochemistry, Engineering or similar)
10 years (with a Bachelor's) or 8 years (with a Master's) relevant experience
5 years of supervisory or people management experience
Strong knowledge of FDA, Medical Device and IVD regulations and quality systems related to complaints, and statistical techniques and the ability to train others related to these requirements
Demonstrated ability to organize complex work assignments and oversee analyst to complete tasks and project on time
Must possess strong investigational skills to determine root cause, identify and implement effective corrective actions
Strong interpersonal communication skills
Strong customer focus and continuous improvement mentality
Excellent written and oral communication skills
Ability to drive Risk Management, escalation and complaint closure processes
Critical thinking skills, including the ability to analyze and trend data and communicate concerns as needed
Benefits
Medical, dental, and vision insurance
401k plan retirement benefits with an employer match
Paid vacation
Sick leave
Participation in a commission plan
Performance-based bonus
Company
Werfen North America
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
Founded in 1959Bedford, Massachusetts, USA
1001-5000 employees
H1B Sponsorship
Werfen North America has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (12)
2023 (10)
2022 (2)
2021 (11)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Giovanni Russi
Chief Operating Officer
Dominique J.
Human Resources Business Partner
Recent News
2025-07-19
2025-05-17
2025-04-04
Company data provided by crunchbase