SUMMARY:

• A career Quality Assurance professional in the Medical Device/Pharma industries under FDA/ISO regulations with a proven track record of problem solving, root cause analysis, streamlining and optimizing processes, developing and fostering supplier relationships, adept at reducing cost of quality and production costs and foster team building.
• Experienced dealing with regulatory audits and agencies. Experienced in handling customer/product complaints and maintaining customer satisfaction. Knowledgeable of Design Controls. Adept at designing databases to provide critically important data to multiple levels within an organization. Adept at fostering interdepartmental relationships to promote information sharing while working towards common goals.
• Over 20 years of experience developing Master Validation Plans, protocols & reports based on risk assessments (FMEAs). Served as Management Representative for several companies. Lead a team through the Malcolm Baldridge Quality Award process and earned a Third Tier award. Provide professional development plans, performance evaluations and mentoring for personnel under my leadership. Foster an open door management policy with employees under my leadership.

TECHNICAL SKILLS:

• FDA 21 CFR 800, ISO 13485, ISO 14971, MDSAP, QMS, Quality Manual, cGMP, DMAIC, CAPA, 510K, Verification/Validation
• IQ/OQ/PQ, MVP/VMP, Root Cause Determination, Problem Solving, Statistical Analysis, Risk (FMEA), Complaints, PV, Remediation
• Auditing, Sterility Validation, Design Control, Change Control, Cleanroom, Trainer, Biocompatibility, Bioburden, Audit Dose Testing, Viable/Non - Viable
• Endotoxin Tests, Environmental Monitoring, Gamma/ETO/Terminal liquid sterilization methods and validation, Sterile Barrier Packaging
• Supplier Management, TSA, QAA, CMO, SPC, AQL, Sampling Plans, Leader/Mentor, NonConformance investigation, DMR /DHR / DHF
• USP Water Systems, Time Management, Database Design, Team Building, Vigilance Reporting, Specification Development, OC Curves
• Control Charts, ASTM, ANSI, AAMI, EU, CE, IVD, DOE, MDR, LAL, VDMax, TOC, CFU, Stability Studies, Accelerated Aging
• Cleaning Validations, USP, UDI, SAL, PMS Data, Calibration, Adverse Event, Cost of Quality, MS Office, 6 Sigma, FAT, URS, MRB.

PROFESSIONAL EXPERIENCE:

Confidential, Morristown, NJ

Quality Engineer

Responsibilities:

• Provide support in the effort to maintain regulatory certifications through the FDA & ISO MDSAP program.
• Helped author 25 SOP’s and other documents to create a new Quality System and Quality Manual to run a satellite production office as part of the MDSAP program.
• Helped Identify suppliers for the ASL and halp manage the CMOs, through Technical Service Agreements (TSA) and Quality Assurance Agreements (QAA) with in-house suppliers & manufacturers both Domestic and in Canada.
• Support OSS, Deviation, CAPA and complaint investigations.
• Responsible for maintaining documentation and the document control system.
• Review and release batches for sale.

Confidential, Parsippany, NJ

Quality Engineer

Responsibilities:

• Provided support for Product Development teams on Design Control activities. Review design validations, complaint reports and labeling. Oversee the Document Change Order process. Designed a database to capture Change Control data and eliminate errors.
• Successfully aided the implementation of a new QMS and obtained ISO 13485(2016) certification within 1 year.
• Responsible for managing the document change control system that averaged 40 changes per month using a Part 11 compliant software system. Achieved a 100% on time implementation record. Developed a database to streamline document change activities. Assisted in developing a periodic document effectiveness schedule.
• Reduced the number of submission errors by 50% by requiring authors to get preapprovals before submission.
• Provide design control support for the product development teams.
• Aided in qualifying new suppliers and CMOs and maintain supplier records for the ASL.
• Responsible for performing CAPA activities.
• Assisted the validation department in reviewing historical validations in support of two new production lines to evaluate whether any retrofitting needed to be performed based on design changes and risk documentation. Reviewed concurrent validation protocols.

Confidential

Quality/Regulatory Compliance Specialist

Responsibilities:

• Schedule, lead and participate in worldwide meetings to address IT Infrastructure software nonconformances.
• Reduced the number of recurring, non-value added training items for new hires by approximately 2% and documented a “Play Book” as a reference for future employees in an effort to reduce training time.

Confidential, Cedar Knolls, NJ

Quality Engineer

Responsibilities:

• Managed the N/C system. Reduced the closeout time from 45 days to approximately 15 days by developing a database incorporating real-time QC data as well as hosting periodic weekly N/C Board meetings.
• Responsible for reviewing and approving Device(Batch) History Records (DHR) for commercial product release.
• Served as the Liaison for customer complaints between the NJ and Florida locations.
• Performed routine CAPA activities.
• Served as a member of the audit team for all internal regulatory audits. (Backroom team member as well as SME)
• Responsible for overseeing the audit dose testing, and ETO sterilization requalification/revalidation.
• Perform quarterly cycle counts on returned & N/C products.

Confidential, North Brunswick, NJ

Manager QA/ Director of Quality/Operations

Responsibilities:

• Aided in the company’s relocation in 1998 and 2013, and re-established manufacturing by validating all equipment, clean room and a USP water system. Brought both projects in on time and on budget.
• Developed the environmental monitoring SOP for the cleanroom and water system establishing alert & action limits.
• Responsible for the day to day operations of the Manufacturing and Quality departments. Qualify, managed and audit suppliers, manage the document change control system, CAPA, N/C & complaint activities. Responsible for all FDA related activities including audits, adverse event reporting, and mitigation activities. Responsible for calibration activities. Responsible for maintaining test method effectiveness. Provide GMP training, develop training plans for those under my leadership, provide performance reviews for technicians and quality engineers under my leadership. Served as Management Representative.
• Develop V&V plans for equipment and manufacturing processes, including sterility and cleaning validations.
• Implemented dual sourcing policy. Obsoleted a test method resulting in $350/year cost savings. Successfully brought company into compliance for the first time in 12 years. Established a periodic sterility requalification and biocompatibility testing SOP. Developed an SOP to avoid equipment down time due to external calibration needs. Streamlined the batch record from a 40 page to a 20 page record, saving approximately 15 ma hours of paperwork/week.

Confidential, Piscataway, NJ

Sr. Quality Engineer / Validation Manager

Responsibilities:

• Managed the day to day validation activities for multiple locations, including developing MVPs, and risk based IQ/OQ/PQ protocols and reports. Provide validation support for Product Development.
• Scheduled and hosted weekly Validation Review Board (VRB) meetings which reduced the approval process by approximately 50%.
• Create pFMEA risk assessments. Perform routine CAPA activities. Qualify new supplies, maintain CMO/Supplier relationships. Provide periodic GMP training to company employees.