Quality Analyst

Kelly Science and Clinical FSP is currently seeking a Quality Analyst for a long-term engagement in Raynham, MA with one of our Global Medical Device clients. This position is onsite. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

Quality Analyst

JOB SUMMARY:

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.

DUTIES & RESPONSIBILITIES:

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

• Comply 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.

Compliance/Regulatory:

• 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.

New Product/Process Introduction:

• 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.

Product Quality, Control & Disposition and Performance Standards:

• 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.

Product/Process Qualification:

• 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.
• 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.

EXPERIENCE AND EDUCATION:

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

Required Qualifications:

• Good technical understanding of manufacturing equipment and processes.
• Good understanding of company GDP and Quality procedures related to software handling.
• Strong/Advanced Spreadsheet (e.g. Excel) skills.
• Inspection knowledge, including basic GD&T skills.
• Low to Intermediate experience using the Labware LIMS Version 7 platform.
• Low to Intermediate experience using the LabVantage Version 8.8 platform.
• Low to Intermediate experience in setting up Master Data from one platform to another.

Preferred Qualifications:

• Six months or more of work experience in a manufacturing environment.
• Strong knowledge and ability to preview, graph and analyze data and be able to present data that facilitates/drives decision-making.
• The ability to perform "hands on" troubleshooting and problem-solving.
• Understanding of GMP/ISO regulations and validation regulations.