Werfen

Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories.  The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing.  Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality.  We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA.  Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA.  Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.

Position Summary:

Responsible for product family oversight in the QA Reliability & Customer Satisfaction function, including: case/complaint review and ensures timeliness for complaint management. Reviews complaint investigation plan for execution, investigates results, complaint file accuracy and ensures timely execution of assigned complaint tasks. Responsible for assuring thorough yet streamlined efficient systems for complaint resolution. Responsible for product family specific systems and documentation which contribute to an effective complaint system compliant with FDA, ISO and Worldwide standards.

Key Accountabilities
Essential Functions:

• Ensures that all potentially reportable complaints are reviewed,  escalated and overall managed  in a timely and efficient manner
• Ensures timely and complete review  of complaints  for  potentially  reportable events
• Ensures timely and complete  review of all complaints
• Provides  approval   signoff  for customer complaint  cases where/when  necessary
• Reviews  inquiries for potentially reportable  complaints
• The lead for the product specific RAW process  including creating RAW lines for new failures, reviewing and updating existing  RAW lines and completion of RAW review and sign off.
• Chairing  meeting  and providing guidance  and direction to the Risk Management team
• Responsible for reviewing post Market surveillance reporting
• Trains and develops  subordinates, as appropriate, to achieve   duties and responsibilities
• Ensures that adequate personnel, equipment and material resources are allocated. Supports the hiring process a needed.
• Responsible for routine reviews of all direct reports, including the mid-year and yearly review.
• Escalates relevant information on product complaints to appropriate product management as necessary
• Coordinates and/or attends meetings with appropriate departments for specific customer complaint issues, determination and resolution of root causes for complaints, product family specific validation  testing requirements  and product family specific reliability  development testing
• Lead role in  the product family specific maintenance of an effective  complaint system which is compliant with FDA, ISO and Worldwide standards & regulations
• Follows regulatory requirements for complaint management
• Provides any additional support to Quality Assurance functions on an as needed basis

Secondary Functions:

• May perform, as professional judgment and experience are developed, an expanded range of complex complaint investigations. Assignments may be specific to instrument type.

Budget Managed (if applicable)

• N/A

Internal Networking/Key Relationships

• To be determined based on department needs

Additional Skills & Capabilities:

• Strong skills with Excel required

Competencies:

• Attention to Detail: Ability to pay close attention to detail is required
• Accuracy: Work is accurate and complete
• Performance Standards: Demonstrated ability to meet department goals
• Communication: Excellent written, verbal and presentation skills
• Discretion: Acts with integrity in all situations and can maintain appropriate confidentiality
• Multi-Tasking: Ability to manage multiple priorities, and support changing business needs
• Collaboration: Ability to work within a team to bring best solutions to the team or customer
• Independence: self-motivated-works under minimal supervision
• Professionalism: Must demonstrate professionalism during all interactions within company, customer and third parties
• Takes Initiative: Serves as a role model for “Quality First” by continuously improving on what matters most to customers
• Problem Solving: Promptly and effectively handles issues and problems
• Decision making: Makes decisions based on data and risk determination

Minimum Knowledge & Experience Required for the Position:

• Master's in Medical Technology or related technical degree or equivalent experience
• Minimum of 5 years in an associated discipline
• Minimum of 3 years supervisory experience
• An underlying understanding of test method applications and instrument/cartridge/reagent operation and/or complaint experience with technical capability
• Knowledge of ISO Quality Systems and FDA requirements for the Medical Device industry
• Risk Management

International Mobility:

• Required: No

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 appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V.

We operate directly in over 30 countries, and in more than 100 territories through distributors.  Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.

www.werfen.com