Quality Analyst

SECTION 1: 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.
SECTION 2: DUTIES & RESPONSIBILITIES
* Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, procedures and guidelines, this position:
General
" 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.
" The following must be included for all positions:
o Responsible for communicating business related issues or opportunities to next management level.
o Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
o Performs other duties assigned as needed.

SECTION 3: EXPERIENCE AND EDUCATION
* o University/bachelor s degree or Equivalent
o Generally, Requires 0-2 Years Work Experience.
SECTION 4:…