Quality Analyst

Quality Assurance Specialist

Establishes and maintains quality assurance programs, procedures, and controls, ensuring that performance parameters of both the products and quality system elements are continually measured to drive improvement initiatives.

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, procedures and guidelines, this position:

• Complies with company policies, procedures, and quality standards, as well as safety and environmental regulations.
• Develops solutions to database problems of basic scope and complexity. Assists in writing standard operating procedures related to inspection process and LIMS system operation.
• Provides backup support to product review and LIMS release functions. Provides backup to good manufacturing practice auditing.
• Directly responsible for the migration of Inspection Plans and master data into Labware and Labvantage LIMS.
• Collaborates with inspectors and outside stakeholders on Inspection plan optimization and clarifications in LIMS or other system as applicable.
• Provides support on day-to-day operation of LIMS, assisting users with issues related to the system, troubleshooting, problem-solving, reports or other as applicable.
• Provides LIMS training to applicable personnel meeting company regulations, guidelines, and procedures.
• Facilitates and monitors LIMS access to applicable personnel as per training requirements and user access requirements.
• Supports LIMS Change Control Activities for inspection plans or new implementations.
• Collaborate with other LIMS administrators to perform improvements to LIMS procedures, master data creation and system handling.
• Works with IT, Business, and/or Technical Quality responsible parties to escalate LIMS issues.
• Monitors LIMS appropriate use and performance as required.
• Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
• Conduct benchmarking to develop more effective methods for improving quality.
• Supports base business, new product introductions, and overall product life cycle management.
• Review/analyze whether current product and processes comply to standards such as the QSRs, ISO 13485, etc.
• Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
• Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.
• Partners with R&D and other Multi-functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
• Ensures RI insights and best practices are considered during creation/updates of new inspection plans.
• Supports new product introduction as part of design transfer.
• Supports activities related to the Material Review Board.
• Conduct investigation, bounding, documentation, review, and approval of non-conformances. Escalation of quality issues as appropriate.
• Supports material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in the laboratory.
• Aids in the accountability of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality.
• Draft, Approve, Execute IQ, OQ, PQ, TMV or Software Validation Production/Process Controls including Control Plans.
• Partners with Global Supply chain, Finished Goods, and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
• Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
• Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
• Develop, interpret, and implement standard and non-standard sampling plans.
• Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
• The following must be included for all positions:
  • Responsible for communicating business related issues or opportunities to next management level.
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
  • Performs other duties assigned as needed.

University/bachelor's degree or Equivalent. Generally, Requires 0-2 Years Work Experience.

Good technical understanding of manufacturing equipment and processes. Good understanding of company GDP and Quality procedures related to software handling. Strong/Advanced…