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Werfen · 4 months ago

QA Manager I

Bedford, MA

Full-time

Onsite

Senior Level, Lead/Staff

10+ years exp

Werfen is a company focused on quality assurance in the medical device sector. The QA Manager I is responsible for overseeing the complaint team, ensuring timely case reviews, managing escalations of potentially reportable complaints, and collaborating with cross-functional teams on investigations and field actions.

Health CareHospitalManufacturingMedical Device

H1B Sponsor Likely

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 complaints 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

FDA regulationsQuality systemsInvestigational skillsStatistical techniquesRisk ManagementInterpersonal communicationCustomer focusCritical thinkingWritten communicationOral communication

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 analysts to complete tasks and projects 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

Company

Werfen

Glassdoor4.0

Werfen is a developer, manufacturer and distributer of IVD testing solutions.

Founded in 1966

Barcelona, Catalonia, ESP

5001-10000 employees

http://www.werfen.com/

H1B Sponsorship

Werfen 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)