Connie C. is a Quality Engineer II at Boston Scientific. She is proficient in Cantonese and English. Colleagues describe her as "I've had the pleasure and privilege of working with my colleague Connie for the past six months on team projects and day to day operations in quality assurance. Connie is a bright and innovative solution-seeker who strives to ideate and implement improvements and solve problems, and is detail-oriented, responsible, diligent, vibrant, collaborative, motivated, and eager to learn new things. She is a fast-learner and is able to manage multiple priorities and adapt well to her environment. She is multi-faceted, bearing knowledge and exemplifying her skills in numerous areas within quality assurance such as supplier management, laboratory equipment management, clinical laboratory material quality control, nonconformance reports, document control, and justification of engineering change orders, in addition to providing cross-functional team support to other departments. She has spearheaded the creation and release of a company-wide controlled glossary and has written concise work instructions and procedures. I highly recommend Connie, as you can rely on her to accomplish and meet goals and enthusiastically take on challenges."
Boston Scientific
View- Website:
- bostonscientific.com
- Employees:
- 50679
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Quality Engineer IiBoston ScientificSan Francisco, Ca, Us -
Sr. Facilities Compliance SpecialistRevance Sep 2024 - PresentNashville, Tennessee, Us -
Facilities Compliance SpecialistRevance May 2023 - Sep 2024Nashville, Tennessee, Us- Investigate deviations for the Facilities, EHS, and Engineering Department and determine if CAPAs are required- Initiate change controls to ensure changes to GMP equipment and GxP computerized systems are introduced in a controlled and coordinated manner- Collaborate with cross functional teams in investigations and support the execution of corrective actions- Collaborate with cross functional teams to support audit readiness for onsite audits (internal or regulatory) as required- Revise Standard Operating Procedures (SOPs) and work instructions for continuous improvement of documentation systems. - Review, track, and provide feedback on Facilities, EHS, and Engineering quality system records to ensure on time closure.- Supports the collection and maintenance of department metrics. -
Quality Assurance SpecialistIntervenn Biosciences Mar 2022 - Oct 2022South San Francisco, California, Us- Provide QA review and oversight of NCRs and assist and collaborate with cross functional teams in investigation and support the execution of corrective actions- Collaborate with the Lab Director(s) and QA Director to prepare out-of-state-license applications for Pennsylvania, Maryland, and New York for the CLIA laboratory- Oversee new and current suppliers to maintain and drive the accuracy of the Approved Supplier List.- Collaborate with cross functional teams to oversee equipment management to ensure new and current equipment were properly approved prior to use in all laboratories- Collaborate with cross functional teams to support audit readiness for onsite audits (internal or regulatory) as required.- Validates the quality of purchased materials based on set acceptance criteria with Incoming Quality Control- Writes, revises, and reviews standard operating procedures to ensure quality objectives are met- Maintains electronic and paper records for training and change control -
Qa Compliance SpecialistGilead Sciences Nov 2019 - Mar 2022Foster City, Ca, Us- Manage aspects of the audit lifecycle: to include scheduling, planning, executing, issuing reports, requesting clarification, issuing observations and closing- Schedule pre-audit meetings with CMOs/CXOs to review audit agenda with the lead auditor and key stakeholders.- Incorporate sound risk management principles for the establishment of the annual audit schedule- Identify compliance risks and escalates issues to appropriate levels of management for resolution- Create, publish, and maintain metrics that measure the health and effectiveness of the audit program- Develop and report trends based on internal and external regulatory observations to better focus the scope of supplier audits- Create audit attestations and other documents as needed for mock FDA Inspections - Filgotinib and Lenacapavir- Manage and drive accuracy of the approved supplier list and ensure that the information for suppliers is accurate in GTrack/Trackwise system- Manage new audit requests and participate in due diligence assessments -
Clinical Research CoordinatorUniversity Of California, San Francisco May 2019 - Nov 2019San Francisco, California, Us- Coordinate clinical trials to understand the use and behavior patterns of nicotine addiction, biomarkers of nicotine exposure, and how to prevent exposure of second-hand smoke in vulnerable populations for the Clinical Pharmacology Research Program- Manage databases, comprehensive datasets, and reports on REDCap- Obtain basic vitals from participants and collected urine samples to administer drug tests at screening visits- Facilitate daily clinical trial activities and served as the main point of contact with participants- Maintain participant confidentiality and complied with HIPAA guidelines while working with high PHI- Coordinate with nurses to create and edit Flowsheets and MD Orders to guide the study visits -
Lead Health Screener At Stanford UniversityStanford University School Of Medicine Nov 2018 - Apr 2019Palo Alto, Ca, Us- Worked as a Lead Health Improvement Program Health Screener for the Stanford Prevention and Research Center- Demonstrated proficiency in performing biometric assessments: blood pressure, height and weight measurements or the equivalent- Provided health screenings for over 7, 000 hospital employees of Stanford Health Care and Stanford Children’s health- Communicated frequently with the PM lead to co-supervise a team of eight health screeners- Maintained participant confidentiality, complied with HIPAA guidelines, and screened ~300 employees per day- Trained new hire employees to be proficient with CardioChek machines and assisted with module training -
Wellness/Immunization Administrative Assistant At Stanford Occupational Health ServicesMaxim Healthcare Services Aug 2018 - Nov 2018Columbia, Maryland, Us- Worked as a wellness/immunization administrative assistant at Stanford Health Care in the Occupational Health Services department via Maxim Healthcare - Provided operational and clerical support in a wellness-and/or immunization-clinic setting to more than 7,000 employees- Assisted with high-volume clinic policies and procedures, setup and break-down of clinics, greeting clients and visitors, maintaining appointments, ensuring completion of paperwork, and data entry -
ServerThe Boiling Crab Oct 2015 - Nov 2018Garden Grove, Ca, Us
Connie C. Education Details
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San José State UniversityKinesiology
Frequently Asked Questions about Connie C.
What company does Connie C. work for?
Connie C. works for Boston Scientific
What is Connie C.'s role at the current company?
Connie C.'s current role is Quality Engineer II.
What schools did Connie C. attend?
Connie C. attended San José State University.
Who are Connie C.'s colleagues?
Connie C.'s colleagues are Natalia Beltran, Dan Clifford, Hayden Emerson, Elvis B., Peter Jones, Ewelina Szymańska, Thomas Doona.
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