Quality Systems Lead Inspector

PURPOSE AND SCOPE:

The Quality Systems Lead Inspector ensures Quality Systems presence on the manufacturing floor.  Responsible for inspection of raw materials, parts components, assemblies and/or finished products. Ensures conformity to established standards, specifications and drawings through the use of precision measuring equipment, tests and visual standards.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Leads the coordination of inspection activities with other Inspectors to ensure the work is performed properly under established company policies and procedures.
• Prepares, performs, and controls raw material/packaging material incoming inspections and Material Inspection Records.
• Assigns lot control identification to all incoming production components (chemical components, packaging components, etc.).
• Samples and inspects packaging and chemical components according to approved procedures to ensure conformance with specifications.
• Verifies and records the receipt of components and their condition upon arrival. Documents condition of nonconforming components (description, photographs, etc.) for Material Review Board (MRB) disposition.
• Performs and maintains process ownership of supplier evaluation activities.
• Maintains effective and professional communication with external vendors/suppliers.
• Assists in scheduling inspection staff and coordinating work activities of the Inspectors
• Participates in cross functional failure investigations and facilitate root cause analysis.
• Leads in the performance and maintenance of calibration services and activities for inspection tools.
• Monitors status of work in progress within the department, assuring the completion of work and issuing of required reports in a timely manner.
• Reviews quality/production records for accuracy, completeness, and conformance to all applicable procedures.
• Presents inspection orientation and verifies adequacy of inspection training for new Inspectors.
• Performs inspections/audits of the process to ensure conformance with SOP procedures and identification as needed.
• Prepares, issues, and reconciles all finished product labels in accordance with established label control procedures. Prepares samples for internal laboratory testing or for shipment to an appropriate testing facility.
• Records, counts, and interfaces with issuing facility, and maintains/adjusts the label inventory as necessary.
• Receives and inspects the incoming product labels.
• Enters data in spreadsheets, as assigned for QS records and trending.
• Assists with validations as required.
• Maintains a clean inspection work area.
• Assists with the testing of raw materials in the Chemistry Lab.
• Assembles device history records (DHR) for issuance to production.
• Leads the coordination and performs reviews of finished DHR's for completeness and correctness.
• Responsible for DHR post production review and compiling - Dry and Liquid.
• Participates in QS Internal Audits to monitor the effectiveness of controls.
• May provide assistance to lower level staff with more general support tasks that require a better understanding of functions, as directed by immediate supervisor.
• Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
• Assist with various projects as assigned by direct supervisor.
• Other duties as assigned.

Additional responsibilities may include focus on one or more departments or locations.  See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

• The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• May occasionally be required to lift and/or move up to 50 pounds.

EDUCATION:

• High School Diploma required; Associate's Degree desirable; and Bachelor's Degree in scientific or engineering strongly preferred
• ASQ, CQIA, CQPA, CQI or Lean/Green Belt certification desired

EXPERIENCE AND REQUIRED SKILLS:  

• 4 - 6 years' experience in Quality Assurance and/or Quality Control in a manufacturing environment.
• Strong organizational skills, and ability to perform work in a team environment with a minimum level of supervision.
• Must be detail oriented and be capable of interpreting drawings/specifications.
• Must be capable of applying inspection/sampling plans/techniques to verify if materials/components conform to the applicable drawings/specifications.
• Must have an aptitude for math with basic algebraic skills and measurement skills.
• General knowledge of GMP regulations and standard quality control inspection techniques.
• Ability to prepare routine administrative paperwork. Records maintenance skills.
• Knowledge of the structure, policies and procedures of FDA regulated facilities (21 CRD Part 820 Medical Devices), and Health Canada regulated facilities, if applicable.
• Experience in the medical device, pharmaceutical, or related industry is strongly preferred.
• Excellent intrapersonal skills and ability to develop positive relationships at all levels of the organization.
• Excellent written and verbal communication skills.
• Ability to work cross-functionally.
• Strong PC skills with Microsoft Office applications including Visio.
• Knowledge of basic quality tools for problem definition, data analysis, solution implementation (PDCA), and control planning; exposure to statistical techniques for monitoring quality trends.
• Exposure to regulatory concepts such as CAPA, non-conformance reporting, and out-of-specification reporting desired.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.