Title:  Quality Specialist, Complaints

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?  

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  

Summary: 

Reporting to the Quality Engineering Manager within Operations this role ensures internal system compliance and customer specifications conformity. Complaint Reporting Specialist to support complaint handling and regulatory reporting activities. This role will ensure the timely and effective closure of internal/external complaint handling.

Requirements:

• Must have a third level qualification in Engineering/Quality/Science.
• Must have 2+ years work experience in a Medical Device manufacturing environment.
• A working knowledge of quality systems such as ISO 13485 is essential.  Experience and knowledge of 21 CFR Part  820 and EU GMP is an advantage.
• Team player who can work effectively and proactively on cross-functional teams.
• Experience/understanding of complaint handling or CAPA processes are desirable
• Must have excellent communication skills both oral and written.
• Auditing experience to the requirements of ISO 13485 / EU GMP / 21 CFR Part 820 is preferred.

                                     Essential Duties and Responsibilities:

• To coordinate and support complaint handling of product complaints received by customer
• Interface on an ongoing basis with customers to ensure requirements / concerns / complaints are communicated and corrective and preventive actions are closed in a timely and effective manner.
• To open, track and maintain records for complaints received by customers.
• Data entry into complaint handling system.
• DHR review of Medical Device to be conducted within the QMS
• Lead investigations into customer / material / product issues to ensure a thorough root cause, containment / corrective and preventive action is implemented. 
• Develop technical product expertise to assess adequacy of complaint information from the field and review of complaint investigations.
• Support complaint trend analysis and issuance of key reports to relevant departments.
• Support risk management, risk analysis and health hazard analysis associated with complaint/post-market information.
• Support responses to Competent Authority queries.
• Understand and ensure compliance with internal procedures and external global regulatory requirements.
• Develop processes and systems in line with best industry practice.
• Executing internal process and system audits.
• Manage quality projects in support of continuous improvement eg. Lean Projects.
• Ensuring the timely and effective closure of day-to-day complaints issues.
• Interface with other departments on a daily basis.
• Coach and drive a culture of compliance and continuous improvement.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all site Environmental, Health and Safety requirements, training and regulations.
• Compliance to all local site company policies, procedures and corporate policies.
• Perform additional duties at the request of the direct supervisor.

West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.