Quality Assurance Engineer

Janice Pevide

Email: abpds4@r.postjobfree.com

Address: ** ****** **.

City: Spring Valley

State: NY

Zip: 10977

Country: USA

Phone: 845-***-****

Skill Level: Experienced

Salary Range: 90

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

iJanice M. Pevide

10 Midway Road

Chestnut Ridge, NY 10977

abpds4@r.postjobfree.com

Home: 845-***-**** Cell: 201-***-****

SUMMARY:

Thirty years experience in Quality Assurance and Regulatory Compliance in the medical device industry.

Solid knowledge of FDA Quality System Regulation and ISO 13485.

Managed the Product Hold process, coordinating global quarantine activities and partnering with Distribution, Operations and Quality to coordinate corrective actions.

Contributed to the design and development of Oracle-based Product Containment functionality. Participated in and subsequently led the project team to complete implementation. Conducted and documented test and validation activities of the new functionality.

Established and implemented Internal Audit process for monthly audits of manufacturing cells, and developed various checklists to ensure consistency and compliance. Led the team of internal auditors; oversaw the audit reporting process and developed metrics to report results. Worked with manufacturing to implement corrective action plans.

Managed document control function; standardized the document development process and documentation requirements; revised procedures and system for improved compliance to FDA regulations. Established a global documentation process for worldwide operations.

Participated in global team to test, validate and implement new web-based complaint system for Strykeras global operations. Coordinated the local OQ, executing test scripts and overseeing user testing. Wrote deviation reports and participated in resolution of deviations.

Developed and conducted in-house employee training programs for cGMP and ISO 9001.

Validated and implemented an on-line imaging system to access current revisions of controlled procedures. As part of a team, developed the user requirements documentation, test scripts, and operating procedures for system users. Conducted Operational Qualification for the documentation module, wrote deviation reports and participated in resolution of deviations.

Interfaced with FDA and Notified Bodies during GMP and ISO inspections.

PROFESSIONAL EXPERIENCE:

Stryker Orthopaedics, Mahwah, NJ 12/95 - Present

Quality Complaint Analyst (2001- Present) a Managed the Product Hold Process, partnering with Operations and Distribution to resolve issues. Coordinated global product quarantine efforts. Contributed to the design, validation and implementation of Oracle-based product containment functionality, resulting in 75% reduction in time to implement containment and improved confidence in the accuracy of containment. Partnered with global distribution centers to execute appropriate containment.

Responsible for review of customer complaints, Medical Device Reporting (MDR) and Medical Device Vigilance (MDV) reporting decisions, timely submission of MDR and MDV reports, interfacing with international affiliates to resolve complaint issues. Team member of global team designated to implement new web-based complaint system, responsible for specifying local user requirements, local OQ, training, documenting deviations and tracking deviation reports to resolution, interfacing with international counterparts to resolve issues. Maintained department procedures for complaint handling.

Lead Auditor (1999-2000) a Revised the internal audit process, trained and oversaw a team of auditors, maintained audit procedures, reports and files. Consulted on corrective actions as a result of audit findings. Established in-house GMP/ISO training process and conducted training for all manufacturing employees. Worked with Operations to coordinate training for new hires.

Manager, Documentation Administration (1995-2000) - Managed Documentation Administration function. Created, revised, reviewed and approved procedures, specifications, and test methods for compliance to FDA regulations and international standards. Assisted and trained document authors to develop standard operating procedures and to refine systems for improved regulatory compliance. Implemented Windows based database for document control, worked with software engineers to develop system performance requirements and validation protocols, oversaw validation testing and documentation, including deviation reports and resolutions. Managed documentation distribution for local and global operations.

Smith & Nephew Endoscopy, Mansfield, MA 3/93 - 12/95

Quality Assurance Engineer - Quality Engineer for metal and polymer orthopaedic implants and instruments. Supervised Quality Assurance Engineering, Document Control, Customer Complaints, Sterility Assurance, and Calibration. Participated in the review and approval of engineering drawings, specifications and test methods. Established a formalized internal audit system; conducted and documented audits for all internal systems and assisted process owners with corrective action and system refinements. Served as co-chair of the Steering Committee for ISO 9001/CE Mark registration, which was successfully achieved in 12 months; developed a Quality Manual and supporting procedures for the Quality System. Developed training materials and conducted in-house training for GMP, ISO, and FMEA for all employees. Member of several Design Control teams.

Medtronic Andover Medical, Haverhill, MA 8/80 - 3/93

Quality Assurance Engineer - Quality Engineer for disposable ECG electrodes and cable and leadwire systems. Supervised Document Control. Developed training materials and conducted in-house training for GMP and SPC programs. Drafted 510(k) submissions and interfaced with FDA to resolve issues. Interfaced with corporate Quality Assurance personnel in the development and manufacture of the companyas only sterile product and formalized the biological monitoring process for sterility assurance. Processed customer complaints and MDRs. Managed the companyas first recall for high volume product with resolution in three months. Participated in the selection and implementation of the companyas first electronic MRP system.

EDUCATION:

Felician College, Lodi, NJ a Bachelor of Arts English Literature May, 2003

Hesser Junior College, Portsmouth, NH - Assoc. of Science, Business Administration January, 1993

ACHIEVEMENTS:

Certified Lead Auditor - 1998

ASQ Certified Quality Auditor since 1991

ASQ Certified Quality Engineer since 1991

Medtronicas Star of Excellence Award for Product Assurance Management - 1985

PROFESSIONAL ASSOCIATIONS:

Member American Society for Quality (ASQ) since 1990

Member Regulatory Affairs Professional Society (RAPS) since 1996

REFERENCES

Available upon request

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