Service & Distribution Quality Manager

at  OrganOx

ABOUT ORGANOX:

OrganOx has been transforming organ transplantation since 2008, leveraging ground-breaking normothermic machine perfusion technology in our flagship product, the OrganOx metra®. This technology helps preserve donor livers for up to 24 hours, in efforts to reduce organ discard rates and facilitate more successful transplants. We are an innovative, fast-paced global medical device company committed to improving transplantation outcomes. As part of our ongoing expansion, we seek a motivated Service & Distribution Quality Manager to join our team.

POSITION SUMMARY

The Service & Distribution Quality Manager is responsible for the Quality processes within the Service organization. This individual will be technical, and customer focused with a proven track record of identifying and resolving complex on-market product quality issues. Additionally, this individual will establish best practices in the complaint intake and investigation process to ensure that the resulting work complies with all regulatory requirements, as well as, company objectives for defect prevention and continuous improvement. The successful candidate is collaborative, has excellent communication skills and is passionate about delivering world-class products that make healthcare more accessible, simpler, and safer. Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive. This is an on-site role in our Oxford facility to ensure effective control of the manufacturing and service documentation, and collaboration with both the Servicing and Quality teams.

SKILLS AND EXPERIENCE

• 5 years of Life Science or medical device industry experience with quality engineering or related field.
• Experience in service and support organization highly preferred.
• 3 years (team management) experience
• Ability to lift, push, or pull up to 50 pounds
• Ability to travel 20-30%
• Excellent technical reporting skills.
• Strong Root Cause Analysis, Design of Experiments (DOE), investigation and troubleshooting experience as related to service activities and complaint investigations.
• A solid understanding of the FDA Quality System Requirements (QSR), and the ability to apply the knowledge to comply with goals and objectives.
• Strong experience with MS Office Products (Word, Excel, Visio, Project, PowerPoint, Outlook, etc.)
• Excellent oral and written communication skills with the ability to present to audiences of varying technical skills and management levels.
• A strong ability to prepare written technical plans and reports in support of engineering changes, product or process validations, and failure investigations.
• Strong focus on meeting customer needs and customer experience.
• Ability to train/mentor direct reports of Quality Engineers and Quality Inspectors.
• Ability to work with cross-functional teams.
• Demonstrated strong attention to detail and “do it right the first time” attitude.
• Knowledgeable with statistical methods

QUALIFICATIONS

• Bachelor’s degree in an Engineering discipline (biomedical, electrical, mechanical, etc.)

• Ensure that Complaint Investigations and records of Servicing activities are thorough, accurate, self-explanatory, and completed promptly into the complaint handling system.
• Provide direction, oversight, and assist technicians in streamlining data intake requirements and establishing an efficient and compliant investigation process. Able to assist in the troubleshooting and solution of complex problems experienced in the field by identification of root cause of failures
• Ensure proper test methodologies and training plans are incorporated.
• Establish Service-related PFMEAs and other activities to support pre-market and post-market risk management activities.
• Coordinate and perform Quality trending of Service data and conduct investigations to identify causes of Servicing and Service-related complaint trends, including issues in Servicing workmanship and Out of Box failures.
• Coordinate and trend data from Service databases to deliver insightful and actionable information related to out of box failures, mean time between failure, complaint/replacement rate, component failure, and service financials.
• Provide ongoing training to Service staff on regulatory requirements associated with complaint investigations and Servicing records.
• Lead service quality review meetings with key stakeholders across departments to derive key trends, actual results vs. the quality goals, and key insights which lead to continuous improvement activities.
• Review and/or approve completed service records and quality documents for accuracy: product quality notifications, standard operating procedures, work instructions, validation reports and protocols, risk assessments, and specifications.
• Participate in New Product Transfer team to assist in developing service repair processes and improving serviceability for new or transferred products.
• Plan, develop and conduct Service Manual and Service work instruction validations (IQ, OQ, PQ), test method validations, inspection method validations.
• Participate in the development and review of engineering change orders that impact servicing activities.
• Perform DHR, Service History record, and PFMEA reviews in support and complaint investigations.
• Lead team of Subject Matter Experts (SME) during complaint investigations, escalations (internal and external), and associated improvements initiatives.
• Assist Customer Service, Technical Support, and Field Service in addressing customer inquiries and concerns. Train and educate those teams in best practices and information gathering.
• Provide management with status updates on failure investigation and escalate issues to maintain timelines and goals.
• Provide guidance to maintain complaint system data integrity and support decision making for recalls and proactive service response.
• Define, create, and publish (documentation and web-based) required spare parts and procedures to enable the execution of service processes in the depot and field.
• Actively monitor market trends and competitive devices to maintain brand awareness and identify development opportunities.
• Create and maintain department metrics and key performance indicators (KPIs) to support the goals of the Quality Organization, Continuous Improvement efforts, and Cost Improvement Projects.
• Establish strategies and drive initiatives for KPIs not meeting goals.
  While the above key responsibilities are the main elements of the titled job the Vice President, Quality may at times request other tasks deemed to be within their capabilities.