We provide IT Staff Augmentation Services!

Quality Associate Resume

TECHNICAL SKILLS:

Engineering/Analysis: Progressive and in Clinical Engineering, Quality Systems/Operations, CAPA, Change Control, FDA Regulatory Affairs, System/Process Validation, Lean Six Sigma methodology, Lean Manufacturing process, scientific testing/analysis, process improvement, and mechanical testing.

Research & Development: Excellent skills in project coordination, team leadership, and process improvement. Decisive, analytical, and driven to offer excellent technical support, supervise projects, and communicate scientific information.

s/Strengths: Energized by challenges, steep learning curves and high - pressure deadlines. Analytical thinker; understand details as well as teh broader opportunities and implications. Self-starter; easily meet deadlines and requirements while performing multiple tasks.

Technology/Tools: Oracle ERP - JDE CRM, ECRI, Trackwise CRM, PMDA, Labelview, Salesforce CRM, Windows 2000/XP/NT, MS Office Suite (Word, Excel, and Access).

PROFESSIONAL EXPERIENCE:

Quality Associate

Confidential

Responsibilities:

  • Develop, execute and review procedures / method validation protocols (IQ, OQ, PQ, TMV and PV) for projects/systems at Baxter North American Technical Services.
  • Supported Global Baxter Field Service Engineers in servicing/maintaining pre-FDA water treatment Reverse Osmosis device at DEKA R&D HQ - Manchester, NH.
  • Supported DEKA R&D Quality Engineers in performing Validation &Verification testing and Hemolysis study on pre-FDA Home Hemodialysis (HHD) device at DEKA R&D HQ - Manchester, NH.
  • Supported Global Baxter Field Service and DEKA Service Engineers in launching pre-FDA Hemodialysis device through Phase 2 Clinical Trials at St. Michael’s Hospital, Toronto, Ontario.
  • Manage reconciliation of Homechoice (Peritoneal Dialysis) devices during receipt and release processes as part of software upgrade FCA.
  • Ensured all Homechoice complaints and devices on hold are flagged upon receipt; performed investigation on devices with any discrepancies.
  • Support Field Service Representatives in release of Hemodialysis device (me.e. Sys1000, ExtraPure RO and Aquarious systems) at customer location during off hours.
  • Support closure of Product complaints by reviewing and reconciling product evaluation reports in PMDA (Post Market Data Analysis System).
  • Execute investigation of non-conformance and implementation of Corrective and Preventive Action (CAPA/SCAR/ICAR) via Trackwise CRM.
  • Review government, regulatory, ISO and corporate polices to ensure all local procedures are current and meet requirements. Create/update SOP's and initiate Change Control via Trackwise CRM based on compliance gaps.
  • Participate in internal facility audits and provide support during corporate/external audits.
  • Support inspection, sampling, and disposition of all medical device parts and labels received from Baxter Facilities and External Suppliers at UPS SCS Vaughan Warehouse to achieve AQL requirements.
  • Support product release and complaint logging at Baxter’s CIVA (Central Intravenous Admixture) Pharmacy Center.

Confidential

Quality Control Technologist -Technical Services

Responsibilities:

  • Help manage and supervise afternoon quality team with meeting daily production targets.Inspect medical devices to ensure they are upgraded and serviced as per teh SOP requirements.
  • Review and verify service documents to ensure compliance to SOP and Good Document Practice (GDP).
  • Train new QC Technologist to perform quality assurance testing on equipments according to manufacturers' guidelines.

Confidential

Technical Services

Responsibilities:

  • Responsible for diagnosing and troubleshooting inbound medical equipment to component level.Maintained and ensured of all test equipment as per company operating policies and procedures.
  • Cross-trained to perform quality assurance testing on equipment that had been repaired and were pending shipping according to SOPs & manufacturers' guidelines.
  • Performed CSA/UL testing as required to certify repairs to quality standards ensuring compliance to cGMP.

Confidential

Clinical Engineer

Responsibilities:

  • Conducted market research by performing queries on medical device databases (like ECRI & Maude) and recommended solutions based on hospital’s usability requirements.Conducted human factors/usability testing on medical devices as part of product evaluation.
  • Train medical staffs and physicians on using latest medical technology.
  • Created clinical trial evaluation tools, processed, analyzed teh results and drafted final reports.
  • Attended meetings to evaluate and negotiate sales of various medical equipments.
  • Conducted medical equipment variance investigation, analyzed data from quality input (like complaints) and filed for reimbursements.
  • Helped maintain Quality Assurance database and searched/filed for Adverse Event reporting on medical devices on FDA’s MAUDE and MedWatch database.
  • Tested various medical devices in teh laboratory as part of engineering evaluation.

Hire Now