QA Manager I

Werfen; Bedford; On-site; GBP 60,000 - 80,000; Full time

Job summary

A global medical technology company in the UK is seeking a QA Manager to oversee the complaint team's operations. The role involves ensuring timely investigations, compliance with regulatory standards, and coordination with cross-functional groups. Ideal candidates must have a Bachelor's degree in a relevant field and significant supervisory experience, along with strong investigational and analytical skills. The company fosters a diverse workplace and encourages applications from all qualified individuals.

Qualifications

• 10 years of relevant experience with a Bachelor's degree or 8 years with a Master's.
• 5 years of supervisory or people management experience.

Responsibilities

• Manage the complaint team for timely investigations.
• Ensure FDA and ISO compliance in complaint management.
• Coordinate with cross-functional teams to resolve complaints.
• Conduct trend reviews and ensure corrective actions.
• Provide updates on complaint status to leadership.

Skills

Strong knowledge of FDA regulations

Project management

Investigational skills

Interpersonal communication skills

Customer focus

Continuous improvement mentality

Analytical skills

Education

Bachelor's degree in Life Science, Biochemistry, Engineering or similar

Job description

Overview

Job Summary

Responsible for overseetlng the day-to day activities of the complaint team, works to assure timely case / complalnt review and assignment. Responsible for managing the escalation process of potentially reportable complaints with attention to country specific reporting tlmeliness The QA Manager works with cross func tional teams to support complaint escalations, investigations and field actions.

Responsibilities

• Manages the complaint team to ensure accuracy and timely risk review and thorough complaint investigations are completed.
• Responsible for product family specific sytems and documentation which contribute to an effective complaint system compliant with FDA, ISO and Worldwide standards.Ensures tlmely and thorough review of all com plaints and inquiries, prioritizing potentially reportable events.
• Escalate any potentially reportable complaint or inquiry, communicates with the crossfunctional 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 remedlate 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 reportjng as necessary
• Responsible for gathering complaint and RAW data for Post Market Surveil lance and updating the RA reports including assessing newly identlfed risks.
• Follows regulatory requirements for complalnt management.
• Establish and maintain a system to review literature and social media for complaints.
• Manages tasks supporting complaint investigations, Including returned parts and external as signments.
• Supports investigation activities and provides guidance for resolving product malfunctions
• Performs other related duties as assigned.

Networking / Key Relationships

• Medical Affairs
• R&D
• Regulatory Affairs
• IT / Cybersecurity
• Global Affiliates
• Operations
• Other technology centers

Qualifications

Minimum Knowledge & Experience for the position

• 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.

Skills & Capabilities

• 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 analyts 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.

Travel requirements : N / A

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity / expression, national origin / ancestry, age, mental / physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact for assistance.

We operate directly in over 30 countries, and in more than territories through distributors. Annual revenue is approximately $2 billion and more than 7, employees around the world comprise our Werfen