Manager, Clinical Quality Svc

• Provide knowledge, training, leadership, motivation, and guidance to ensure staff have a clear understanding of tasks, responsibilities, business goals and customer demands
• Provide 24-hour support for Quality related issues either by phone or email
• Be observant of processes, performance, and behaviors, focusing on continuous improvement
• Manage budgets and plans for business growth
• Compile, analyze and report key departmental Quality metrics (Product HOLDs, Line Clearance Observations/Failures, Near Miss events and Right First Time metrics)
• Provide support via emails, phone, conference calls, Quarterly Business Review/meetings, tours, audits and investigations
• Perform and participate in tours of functional areas for internal, customer and regulatory audits. Identify risks, observations, and controls. Communicate results and develop action plans to resolve issues
• Ensure Quality issues are resolved appropriately and report results to Quality and Production Management
• Oversee incoming, in-process and finished goods inspections of products to ensure conformance to established standards
• Investigate root causes of quality events/defects and recommending solutions
• Manage non-conforming product, materials and reports (NMRs, Product HOLDs, Line Clearance Failures)
• Manage Batch Record Right First Time program
• Ability to partner and collaborate with functional departments
• Primary Quality Contact for Project Management regarding operational issues
• Oversee retention of PCI, customer retain samples (retain cage) and outbound retain shipments
• Lead and drive improvement / harmonization initiatives across multiple facilities
• Ensure Performance Metrics (Safety/Quality/Regulatory/Delivery), goals and objectives are on track for completion
• Report and escalate to Senior Management of any potential risks that impact Quality
• Select, supervise, empower, coach, develop and retain a team of qualified individuals through effective employee development, performance management, succession planning and recognition
• Ensure the appropriate team structure is in place by performing workload analysis to manage headcount and to ensure we deliver on customer and business commitments
• Establish quality team and individual goals and objectives in alignment with Clinical Customer Focused Team goals and customer requirements
• Ensure strong alignment and coordination with other business units and functional groups. Collaborate on best practices with other Clinical Quality Managers and leadership
• Facilitate the daily quality team performance to ensure goals and objectives are met and to build a culture of safety, quality, performance, customer service and continuous improvement
• Oversee investigations, consumer complaints, CAPAs, DEA activities, NMR issues, etc.
• Collaborate with the other team members to manage the team performance metrics and customer scorecard
• Collaborate with the appropriate Account Executive and Sr. Project Manager to coordinate and facilitate the customer Quarterly Business Reviews
• Provide proactive quality assurance and risk assessment using FMEA, HCCAP, and Quality by Design
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules
• This position may require overtime and/or weekend work
• Attendance to work is an essential function of this position
• Performs other duties as assigned by Manager/Supervisor
• Deliver MRO parts to PRTs on the lines in a timely fashion. Create Work Orders to document repair, time and parts issued
• Assist in determining needed parts that are not stocked, coordinate expedited delivery if necessary. Determine appropriate stocking levels
• Work with vendors on parts that need recoating/re-rubbering/repairing. Also work with vendors who accept old parts as trade in. Coordinate with radio vendor on repairs/warrantied work. Ensure scrap material is picked up in a timely manner
• Make vinyl, and engraved signs per internal customers instructions. Maintain stock levels of all needed sign supplies. Make Asset Tags as requested
• Assist in receiving stock items with entry to system, replenishment of shelves
• Perform routine spare parts cycle counting on a weekly basis
• Perform Maintenance and repair on gearboxes, glue nozzles and other repairable equipment. Coordinate with Machine Shop on sharpening of all blades

• Bachelor's Degree in a related field and/or 7-10 years related experience and/or training
• Statistical and Advanced Mathematical Skills
• Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs
• High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms

Project Accomplishment Experience

• paid time off
• health insurance coverage (including dental and vision)
• a flexible spending account
• a 401(k) plan
• eligibility for an annual performance bonus