Laboratory Supervisor

Laboratory Supervisor, Fresenius USA Manufacturing Inc., a Fresenius Medical Care N.A. company, Irving, Texas

Will be responsible for the day-to-day technical, scientific, and administrative management of the Laboratory Department’s operation and personnel. Will act as a liaison between the Quality Systems Engineering and Laboratory scientific staff to complete lab modifications, process changes, and ensure safety compliance. Will also be responsible for managing and train new scientific staff in the general use and function of designated instrumentation, company procedures, and product quality requirements, and will create and refine user protocols for general use.  Specific duties and responsibilities include: 

· Establishes and maintains a Quality Control Program in conjunction with the Sr. Manager for Quality Systems, ensures the program is appropriate for the product testing performed and ensures acceptable performance standards from initial receipt of the specimen, through specimen analysis and reporting of results. Conduct validation training and ensure employee adherence to necessary company protocols.

· Supervises the daily operations of the Quality Control Laboratory and Quality Inspection teams, including but not limited to establishing goals, assigning tasks, and maintaining schedules.

· Provides direct supervision of the Quality Control teams through ongoing leadership and guidance to ensure lab and inspection operations and production comply with all necessary company, regulatory, and quality standards.

· Oversees and ensures daily production/testing deadlines, adherence to company protocols and processes, and quality standards are maintained through appropriate management of available resources.

· Directs and maintains high efficiency and productivity while ensuring adherence to company’s product and quality standards and meets turnaround time goals.

· Maintains up-to-date Standard Operating Procedure (SOP) and Procedure Manuals. Includes Technical Procedure Manuals, Administrative Manuals, Safety Manuals for the Laboratory team.

· Manages and develops investigational quality systems studies/experiments, test evaluations, method comparisons, and a variety of process improvement projects in accordance with company processes, procedures, and policies.

· Analyzes the impact of product quality testing data and other related factors, and exercises judgment within the company and regulatory-defined procedures and policies to determine appropriate action.

· Administers company policies, processes, and procedures that directly affect subordinate employees and the products and units produced by the Laboratory Department.

· Communicates internally and externally with suppliers, vendors, and/or customers; may work with external companies or vendors to resolve routine product or supplier quality problems and/or facilitate workflow.

· Provides and presents technical, safety, and quality compliance guidance to team members and direct reports.

· Oversees and maintains Inspection Ready status for any state-related, or other applicable regulatory agencies, to ensure continued compliance in the event of internal or external audits.

· Develops, maintains, and monitors the effectiveness of key functional metrics in conjunction with department goals and under the direction of the Sr. Manager, Quality Systems; coordinates and liaises with Quality Assurance, Medical, and other internal teams as needed to complete laboratory modifications and ensure safety compliance.

Requirements:

Position requires a Bachelor’s degree (or an equivalent foreign degree) in Industrial, Chemical or Biomedical Engineering or a closely related field and 2 years of experience as a Quality Engineer in a manufacturing environment. Must also have 2 years of experience (which can have been gained concurrently with the primary experience requirement above) working with the following:

· ISO 13485, 21 CFR Part 820.100 and participating in corporate, internal and external audits (FDA and COFEPRIS);

· Trackwise and Windchill platforms and MINITAB to manage quality assurance projects and harmonize projects at multiple sites;

· Performing and managing product/complain investigations (CAPAs and NCs) in a medical device manufacturing environment;

· Developing and maintaining Master Production Records for medical devices or drugs;

· SAP material management, creation of materials, specification, bill of materials, inspection;

· Supplier quality nonconformance and supplier notifications; and

· Management of contract manufacturing organization (CMO) complaints including developing  Quality Agreements for CMOs, Third party Vendors and new parts/services qualifications.