Senior Software Qa Engineer - Compliance (Product Transfer)
Current
Sep 2021 - Present
AeroLeads people directory · profile
Amy O. Email & Phone Number
Senior Software QA Engineer - Site ESQ SME | Quality Assurance | Computerized System Validation | New Product Transfer | Software Validation | Equipment Qualification
at
Boston Scientific
1 work email found
@bsci.com
LinkedIn matched
✓ Verified July 2026
4 data sources
Profile completeness 100%
Current company
Role
Senior Software QA Engineer - Site ESQ SME | Quality Assurance | Computerized System Validation | New Product Transfer | Software Validation | Equipment Qualification
Location
Bayan Lepas, Penang, Malaysia
Company size
Who is Amy O.? Overview
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Quick answer
Amy O. is listed as Senior Software QA Engineer - Site ESQ SME | Quality Assurance | Computerized System Validation | New Product Transfer | Software Validation | Equipment Qualification at Boston Scientific, a with 10 employees, based in Bayan Lepas, Penang, Malaysia. AeroLeads shows a work email signal at bsci.com and a matched LinkedIn profile for Amy O..
Amy O. previously worked as Senior Software QA Engineer - Compliance (Product Transfer) at Boston Scientific and Senior Software QA Engineer (Product Transfer) at Boston Scientific. Amy O. holds Bachelor Of Science (B.Sc.), Computer Science from Coventry University.
Company email context
Email format at Boston Scientific
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*@bsci.com
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Profile bio
About Amy O.
Lead Equipment Qualification and Software Validation activities in term of quality and compliances. Responsible for providing compliance leadership and expertise in qualification and validation of replicate custom automated manufacturing equipment. Provide input into validation protocols and strategies and ensuring that validations are completed in a compliant manner. Served as the equipment and software qualification expert for the implementation and documentation of validation for automated manufacturing equipment and computer/software/automation validation. Proficient in o US FDA (21 CFR 11, 820) and EU EMEA regulationso ISO 13485:2016o ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems
Listed skills include Open Text Livelink, Sap, Sap R/3, Troubleshooting, and 6 others.
Current workplace
Amy O.'s current company
Company context helps verify the profile and gives searchers a useful next step.
Boston Scientific
9 roles
Amy O. work experience
A career timeline built from the work history available for this profile.
Senior Software Qa Engineer (Product Transfer)
Aug 2022 - Oct 2022
Software Qa Engineer Ii - Compliance (Product Transfer)
Projects:1. RP19 Project: Balloon Catheter Product Transfer Project from Galway, Ireland to Penang Mustang™ Line Transfer2. RP19 Project: Balloon Catheter Product Transfer Project from Maple Grove, USA to Penang Quantum Maverick/Maverick 2™ Line TransferSummary:Lead the Equipment Software Qualification activities in term of quality and compliances deliverables. Responsible for providing compliance leadership and expertise in acceptance testing and qualification of replicate custom automated manufacturing equipment. Provide input into protocols and ensuring that qualification were completed in a compliant manner. Database Qualification and Implementation for RP19 Balloon Product Transfer.Summary:Established database management systems in term of quality and database qualification deliverables. Supported, reviewed and approved the development of qualification documentation creation, security procedures and guidelines.
Apr 2019 - Sep 2021
Software Quality Engineer Ii
RP19 Project: Balloon Catheter Product Transfer- FAT support for repeat build (replicated) custom automated manufacturing equipment
Jan 2021 - Apr 2021
Software Quality Engineer Ii
RP19 Project: Balloon Catheter Product Transfer - Short Term Assignment
Oct 2019 - Dec 2019
Software Quality Engineer Ii
RP19 Project: Balloon Catheter Product Transfer - Short Term Assignment
Jun 2019 - Oct 2019
Quality Computerized System Validation (Jjsv Groningen, Netherlands)
- Q-CSV Computerized System Validation Remediation Project.
Oct 2018 - Jan 2019
Site Project Leader Computerized System Validation (Jjsv Kulim, Malaysia)
- Lead the Computerized System Validation Remediation Project.- Responsible for the CSV of Automated Manufacturing Systems and Lab Instrument Systems
Mar 2017 - Nov 2018
It Application Executive Ii
Implementation and roll out of business application projects in QM department across B.Braun Subsidiaries in APAC region.
Feb 2010 - Mar 2017
Team & coworkers
Colleagues at Boston Scientific
Other employees you can reach at bostonscientific.com. View company contacts for 10 employees →
FA
Francisco Agüero Lobo
Colleague at Boston ScientificAlajuela, Costa Rica
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DV
Dia Vang
Colleague at Boston ScientificMinneapolis, Minnesota, United States
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HN
Harishankar Natesan, Phd
Colleague at Boston ScientificMinneapolis, Minnesota, United States
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MS
Manikanta Sai Maddali
Colleague at Boston ScientificGreater Boston, United States
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SC
Stephen Carew
Colleague at Boston ScientificIreland
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SB
Seth Bina
Colleague at Boston ScientificSt Paul, Minnesota, United States
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JA
James A. Markfort Jr.
Colleague at Boston ScientificGreater Minneapolis-St. Paul Area, United States
View →
RM
Rachel Madders
Colleague at Boston ScientificCork, County Cork, Ireland
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EG
Elizabeth Gonzalez
Colleague at Boston ScientificPuerto Rico
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FG
Fiona Gannon
Colleague at Boston ScientificGalway Metropolitan Area, Ireland
View →
Francisco Agüero Lobo
Colleague at Boston ScientificAlajuela, Costa Rica
View →
DV
Dia Vang
Colleague at Boston ScientificMinneapolis, Minnesota, United States
View →
HN
Harishankar Natesan, Phd
Colleague at Boston ScientificMinneapolis, Minnesota, United States
View →
MS
Manikanta Sai Maddali
Colleague at Boston ScientificGreater Boston, United States
View →
SC
Stephen Carew
Colleague at Boston ScientificIreland
View →
SB
Seth Bina
Colleague at Boston ScientificSt Paul, Minnesota, United States
View →
JA
James A. Markfort Jr.
Colleague at Boston ScientificGreater Minneapolis-St. Paul Area, United States
View →
RM
Rachel Madders
Colleague at Boston ScientificCork, County Cork, Ireland
View →
EG
Elizabeth Gonzalez
Colleague at Boston ScientificPuerto Rico
View →
FG
Fiona Gannon
Colleague at Boston ScientificGalway Metropolitan Area, Ireland
View →
1 education record
Amy O. education
-
Coventry University
FAQ
Frequently asked questions about Amy O.
Quick answers generated from the profile data available on this page.
What company does Amy O. work for?
Amy O. works for Boston Scientific.
What is Amy O.'s role at Boston Scientific?
Amy O. is listed as Senior Software QA Engineer - Site ESQ SME | Quality Assurance | Computerized System Validation | New Product Transfer | Software Validation | Equipment Qualification at Boston Scientific.
What is Amy O.'s email address?
AeroLeads has found 1 work email signal at @bsci.com for Amy O. at Boston Scientific.
Where is Amy O. based?
Amy O. is based in Bayan Lepas, Penang, Malaysia while working with Boston Scientific.
What companies has Amy O. worked for?
Amy O. has worked for Boston Scientific, Johnson & Johnson Vision, and B. Braun Medical.
Who are Amy O.'s colleagues at Boston Scientific?
Amy O.'s colleagues at Boston Scientific include Francisco Agüero Lobo, Dia Vang, Harishankar Natesan, Phd, Manikanta Sai Maddali, and Stephen Carew.
How can I contact Amy O.?
You can use AeroLeads to view verified contact signals for Amy O. at Boston Scientific, including work email, phone, and LinkedIn data when available.
What schools did Amy O. attend?
Amy O. holds Bachelor Of Science (B.Sc.), Computer Science from Coventry University.
What skills is Amy O. known for?
Amy O. is listed with skills including Open Text Livelink, Sap, Sap R/3, Troubleshooting, It Management, Active Directory, Cross Functional Team Leadership, and Erp.
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