Maintain and prioritize the metrology schedule through the metrology request system.
Supervise the day-to-day activities in the Metrology group to maintain the instrument quality which includes:
Preventative maintenance
Troubleshooting
Repairs
Instrument asset management and life cycle
Laboratory facilities equipment
Prioritize continuous improvement initiatives and development of inspection routines including disaster recovery and change control documentation
Schedule equipment downtime planning with Program Managers and Quality Supervisors to minimize impact to business bottom line
Assure that direct reports have been adequately trained for their role
Create strategies to control costs, reduce risks and improve productivity.
Write and execute IQs, OQs, PQs, and validation protocols for new equipment installation, movement, or software upgrades.
Review and approve documents such as investigations, work instructions, SOPs, ECRs, risk assessment and deviations
Collaborate with Operations and Facilities Management to maintain and improve laboratory facility
Collaborate with vendors/suppliers to ensure instrument needs within Analytical Services are communicated and implemented. Collaborate with Calibration SME to manage calibration requirements for measurement equipment
Collaborate with Quality to maintain compliance of metrology cleanrooms areas
Provide support and assistance with equipment, instrument and facilities 24/7 to maintain operations
Research and recommend new instrumentation to increase compliance and efficiency in Analytical Services
Maintain metrics for instrument repair history and response time
Assist and participate in audits
Provide budgeting information for new instruments, service agreements, etc
Keep current with new technologies and cGMP regulations.
Implement continuous improvement/lean activities and events for the group.
Performs other duties as assigned based on business needs.
Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
Exhibits regular, reliable, punctual and predictable attendance.
Preferred Knowledge, Skills and Abilities:
Education or Equivalent Experience: Bachelor's in Engineering
General Experience: 8-10 years of experience
Supervisor experience: At least 2 years of experience
Experience programming one or more of these OGP, Micro-Vu, or PCDIMIS measurement systems
GR&R
Computer Skills
Proficiency reading blueprints
Ability to meet deadlines
Excellent communication ability
Strong problem-solving skills
Strong understanding of Geometric Dimensioning and Tolerancing (GD&T)
Demonstrate understanding of QC and/or Six Sigma skills such as Control, Run, and Pareto Charts, Histogram, Scatter Plot, Gantt chart, Fishbone Analysis and Process Capability.
Travel Requirements:
Physical & Mental Requirements:
Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics. Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition. Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality.
May stand or sit for extended periods of time. Must transport oneself to and from other areas of the facility and travel to other divisions when necessary. Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues. Hearing ability should be sufficient to hear audible alarms from distances up to 150ft.
The ability to be able to lift and carry various items up to 50lbs.