Arshia Alim
Morris Plains,NJ
Summary
Quality engineering professional with strong focus on team collaboration and achieving results. Demonstrated success in medical device industry in areas of complex strategic Quality initiatives while operating at both the strategic and tactical level. A decisive leader who leads key business decisions and drives businesses forward through data, process discipline and effective team building.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Global Sr. Quality Engineering Manager
BD Pharmaceutical Systems
03.2020 - Current
- Quality Engineering Leader for the combination drug-device products; Advanced Drug Delivery Systems (ADDS) -Wearable Injector Platforms
- Build QMS to support electromechanical devices with software and/ or SaMD to comply with IEC 62304 and IEC 60601
- Business Process Owner for Risk Management – leading and driving change on using risk management to prevent problems to happen
- Lead a team of ten (10) Product Quality Engineers across different regions (US and EMEA)
- Oversee design and manufacturing activities for the design and development of drug delivery platforms across the US and EMEA
- Lead design and reliability activities related to Design, Manufacturing and Reliability practices
- Lead long term strategies for the platforms – related to product design, customer service, supply chain and customizations
- Establish, monitor and provide input for the product performance metrics
- Drive resolution of critical product quality/ compliance issues identified
- Oversight of all elements of the QMS for the platforms including CAPA, complaints, deviation etc
- Lead external audits, quality agreement negotiations with customers
Quality Manager
Zimmer Biomet
01.2014 - 03.2020
- Quality Leader for the Trabecular Metal Technology business for New Product Introductions and Sustaining Operations
- Provide leadership and support for strategic growth and quality excellence activities
- Lead business townhalls to report on quality initiatives, strategies, and scorecards
- Ownership of developing and managing budgets and reporting on financials
- Lead an organization of up to forty (40) quality associates, including Engineers, Supervisors, Microbiologist and Technicians
- Negotiate and exchange information with all levels of management
- Performance management of all direct reports including goal setting, performance review and development plans
- Led successful third-party audits and FDA inspections with no observations – as Site Quality Lead
- Establish and manage KPI Transformational Metrics to drive process improvements, perform strategic planning, and drive accountability throughout the QA organization
- Lead projects related to supply continuity, capacity expansion, cost reduction, product improvements and line extension
- Successfully led compliance projects – UDI Direct Park Marking and EU-MDR for the site/ business
- Process owner for internal NCR process, CAPA, Health Hazard Analysis, Product Holds, Environmental Controls, Complaint Handling, Validation, Design Controls, Product Release and Calibration
Project Manager
Zimmer Biomet
01.2014 - 08.2015
- Lead a two-year quality remediation project with shared responsibilities throughout the organization focussing on production and process control, validations, design controls and CAPA
- Site lead for Production and Process Controls workstream - test method validation activities
- Develop strategic roadmap to excellence in process validation
- Lead all area of project planning to ensure successful completion of the business-critical project
- This included project planning, execution, budgeting, resourcing and periodic measure of project/ program progress through metrics
Sr. Quality Engineer I & II
Zimmer TMT
07.2011 - 01.2014
- Quality Engineering Lead for New Product Development Projects for Spine, Reconstructive and Surgical Divisions
- Lead continuous improvement projects and various sustaining product activities including but not limited to customer complaints, nonconforming product handling, health hazard evaluations, stock investigations, CAPA, process validation, new product development and management review
- Lead site to site manufacturing transfer after acquisition
- Manage team of Quality Engineers, Technicians/ Inspectors and Interns
Process Engineer
Boston Scientific
08.2008 - 08.2009
- Lead New Process Development and Process Improvement Activities for the Urology Division
Education
Master of Science - Biomedical Engineering
University of Toledo
Toledo, OH01-2007
Skills
- Quality Management
- Lean Six Sigma Black Belt
- Quality Strategy and Performance
- Quality Integration/Separations for new acquisition and spin-off
- Operations Quality
- Design Quality
- Risk Management
- Building high performance teams
Certification
Certified Lean Six Sigma Black Belt
Certified Lead Auditor
Languages
English
Native or Bilingual
Hindi
Full Professional
Timeline
Global Sr. Quality Engineering Manager
BD Pharmaceutical Systems
03.2020 - Current
Quality Manager
Zimmer Biomet
01.2014 - 03.2020
Project Manager
Zimmer Biomet
01.2014 - 08.2015
Sr. Quality Engineer I & II
Zimmer TMT
07.2011 - 01.2014
Process Engineer
Boston Scientific
08.2008 - 08.2009
Master of Science - Biomedical Engineering
University of Toledo
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