Laboratory Supervisor

Fresenius Medical Care•Irving, TX

1d•Onsite

About The Position

Fresenius USA Manufacturing Inc., a Fresenius Medical Care N.A. company, is seeking a Laboratory Supervisor in Irving, Texas. This role is responsible for the day-to-day technical, scientific, and administrative management of the Laboratory Department’s operation and personnel. The supervisor will act as a liaison between Quality Systems Engineering and Laboratory scientific staff to complete lab modifications, process changes, and ensure safety compliance. Additionally, they will manage and train new scientific staff on instrumentation, company procedures, and product quality requirements, and will create and refine user protocols.

Requirements

Bachelor’s degree (or an equivalent foreign degree) in Industrial, Chemical or Biomedical Engineering or a closely related field
2 years of experience as a Quality Engineer in a manufacturing environment
2 years of experience working with ISO 13485
2 years of experience working with 21 CFR Part 820.100
2 years of experience participating in corporate, internal and external audits (FDA and COFEPRIS)
2 years of experience working with Trackwise and Windchill platforms
2 years of experience working with MINITAB to manage quality assurance projects and harmonize projects at multiple sites
2 years of experience performing and managing product/complain investigations (CAPAs and NCs) in a medical device manufacturing environment
2 years of experience developing and maintaining Master Production Records for medical devices or drugs
2 years of experience with SAP material management, creation of materials, specification, bill of materials, inspection
2 years of experience with supplier quality nonconformance and supplier notifications
2 years of experience with management of contract manufacturing organization (CMO) complaints including developing Quality Agreements for CMOs, Third party Vendors and new parts/services qualifications

Responsibilities

Establishes and maintains a Quality Control Program in conjunction with the Sr. Manager for Quality Systems, ensuring 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.
Conducts validation training and ensures 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, including Technical Procedure Manuals, Administrative Manuals, and 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.