Summary
Overview
Work History
Education
Skills
Accomplishments
Affiliation
Skills Roles
References
Languages
Timeline
Generic

Aresh Gutta

Mississauga,ON

Summary

Skilled at preparing and submitting regulatory documentation, including reviewing materials, technical data and accuracy of filings. Articulate and personable with exceptional data analysis, report writing and recordkeeping abilities. Experienced administrative professional knowledgeable about registrations, audits, inspections and aspects of aviation products industry regulatory proceedings. Special skill in managing complex documentation, reports and data for regulatory reporting and compliance. Exceptional public relations skills.

Overview

47
47
years of professional experience

Work History

Quality and Regulatory Specialist Manager

Celestica Mississauga (Honeywell Integration)
03.2014 - Current
  • Enhanced regulatory compliance by developing and implementing robust policies and procedures.
  • Streamlined regulatory submission processes for increased efficiency and reduced approval timeframes.
  • Conducted thorough risk assessments to identify potential compliance issues and develop effective mitigation strategies.
  • Collaborated with cross-functional teams to ensure successful product launches in line with relevant regulations.
  • Strengthened relationships with regulatory authorities through transparent communication and proactive engagement.
  • Managed complex regulatory projects, ensuring timely completion and optimal outcomes.
  • Provided expert guidance on regulatory requirements, supporting the development of compliant products and services.
  • Led training initiatives to increase organizational understanding of evolving regulations and industry best practices.
  • Developed comprehensive documentation for regulatory submissions, resulting in expedited approvals.
  • Optimized internal audit processes, identifying areas for improvement in regulatory adherence.
  • Established a strong culture of compliance throughout the organization by promoting awareness and accountability at all levels.
  • Coordinated responses to inquiries from regulators, demonstrating commitment to transparency and cooperation.
  • Facilitated smooth integration of acquired companies into existing compliance frameworks by conducting thorough due diligence assessments.
  • Managed Nadcap Audit program, including establishment of procedures, process instructions. Overseen self assessment audits to ensure meeting all requirements of the customer and the audit checklists.
  • Established QMS (Quality Management System) based on AS9100/AS9110/ ISO 9001 requirements with documentation, risk assessments, SWOT analysis and management review process.
  • Established document control, training database, internal audit checklist and self-assessment audits.
  • Ensured timely establishment of Transport Canada manual and training requirements.
  • Ensured timely renewal of licenses and registrations through meticulous tracking systems, preventing lapses that could impact business operations.
  • Achieved periodic audits for AS9100/AS9110/ ISO 9001, Transport Canada along with bilateral requirements, CASE audits, DCMA audits and Nadcap audits.

Quality Engineering Technical Support

Celestica International Inc.
01.1998 - 03.2014
  • Controlled all aspects of quality operations for manufacturing of system build, box build, mechanically assembled products
  • Supervised and trained inspectors for random sampling, inspection, final product audit, post-pack audit
  • Performed in house audits
  • Initiated, assessed Corrective Action Reports, Preventive Action Reports
  • Performed and supervised Audits of in-coming parts
  • Issues with vendor followed with RPIs,RTVRs,SCARs
  • Non-conforming material analyzed with Material Review Boards
  • Initiated and tracked corrective actions to prevent further NCM
  • Reviewed product specifications for prototypes and updating manufacturing process instructions
  • ISO compliance audits followed regularly
  • Important roles played in external audit preparation and worked with external ISO teams like BSI, QMI to correct any non-conformances
  • Initiated and tracked training (initial and advanced) for all employees including Adecco contractual employees
  • Use of Analytical tools like UCL/LCL charts, Six Sigma (DMAIC), SPC Systems
  • To continuously improve the process at lowest of the cost
  • Use of real time automated tools like Real-time charting and alarms
  • Web enabled user interface and reporting; real time remote process monitoring.3D rule monitoring and post-defect escalation procedures
  • To keep the process under control as per allowable tolerance
  • Determine ongoing acceptability of material, personnel and process with respect to new and existing product lines
  • To continuously maintain the process in spite of high variable volume like new employees influx, new products from a vendor
  • Effectively communicate with various support systems (internal and external)
  • Effective communication is a key to any success and use of current technologies like email, established reporting databases, queries etc
  • Keeps all concerned teams abreast of real time picture
  • Six Sigma and Lean Manufacturing models integrated with our quality team
  • My proficiency in Six Sigma is a Green Belt project supporter and analyzer
  • Controlled Calibration audit and constant monitoring achieved using escalation alarm system on expiry of tools like torque drivers etc.We use many tools which on daily use may go out of its original settings
  • To maintain correct and effective usage we periodically calibrate the tools
  • Designed and applied process instruction, off-specs and process changes documentation regularly
  • As the process is always under continuous improvements the instructions to manufacture such product needs upgrades and changes
  • Documentations are always reviewed and revised as per needs
  • Overall quality duties of the team regulated and monitored
  • There are many other facets of quality assurance like our own performance is continuously evaluated and monitored in terms of improvements done in dollar value
  • Presentation of periodic quarterly reports in meetings.
  • Improved engineering project efficiency by providing technical support to engineers and project managers.
  • Streamlined documentation processes for more accurate record-keeping and easier access to critical information.
  • Assisted in the development of technical drawings, ensuring clarity and precision for successful project completion.
  • Conducted thorough research on engineering materials, contributing to informed decision-making in procurement and design stages.
  • Collaborated with cross-functional teams to ensure seamless communication and coordination throughout project lifecycles.
  • Enhanced workplace safety by conducting regular equipment checks and promptly addressing any issues identified.
  • Facilitated timely completion of projects by effectively managing priorities and meeting deadlines under pressure.
  • Contributed to sustainable engineering practices by implementing energy-efficient solutions in various projects.
  • Reduced design errors by meticulously reviewing technical documents before submission to clients or regulatory agencies.
  • Supported the maintenance of high-quality standards for engineering deliverables through rigorous testing procedures.
  • Optimized inventory management processes, resulting in reduced waste and cost savings for the organization.
  • Aided in the preparation of comprehensive reports detailing project progress, challenges, and successes for senior management review.
  • Simplified complex engineering concepts for non-technical stakeholders, fostering greater understanding across departments.
  • Developed strong working relationships with suppliers, securing favorable terms on equipment and materials purchases.
  • Expedited issue resolution during construction phases by proactively identifying potential problems and suggesting effective solutions.
  • Demonstrated adaptability by quickly learning new software programs and incorporating them into daily work tasks, increasing overall productivity levels within the team.
  • Participated in ongoing professional development opportunities, staying current with industry advancements and best practices for continuous improvement efforts within the organization.
  • Ensured compliance with relevant regulations by diligently maintaining up-to-date knowledge of codes/standards within respective industriescategories.
  • Advanced quality assurance initiatives by collaborating with engineering team members to develop robust testing protocols for newly designed or modified products.
  • Cultivated a positive working environment by fostering open communication and actively seeking feedback from colleagues to improve individual performance and overall team efficiency.
  • Used various tangible and verbal techniques to solve problems with equipment or dispel disagreements between associates.
  • Followed proper documentation and standard engineering processes.
  • Established labor and method standards for processes in plants.
  • Worked to minimize and maintain engineering costs and plant.
  • Communicated operational activities, priorities and problems with management engineers and supervisors.
  • Performed routine maintenance and replaced worn parts.
  • Completed projects by effectively applying engineering, technical, and maintenance procedures.
  • Treated classified data with utmost discretion, following military and federal protocols.
  • Implemented schematics, diagrams, and written, and verbal descriptions to effectively solve engineering project issues.
  • Conducted passive and active sonar searches for suspected targets.
  • Set up, calibrated and operated engineering equipment.
  • Tracked locations of nearby submarines by using equipment, strong analytics and mathematics skills.
  • Provided extensive training and mentoring to fellow personnel to convey experience and expertise in sonar and acoustic equipment and enhance team performance.
  • Improved product quality by customizing tools and eliminating variability.
  • Compiled data and generated graphs to interpret results and suggest key operational improvements.

Quality Control

Excel Pharmaceuticals Pvt Ltd
01.1994 - 01.1998
  • Product line GMP compliance .Ensuring that products are produced and marketed in accordance with government approvals and specification requirements
  • Working with approving team for all decisions in conjunction with Indian FDA, safety boards, ISO auditors, excise, sales tax and provincial bodies to accomplish periodical certifications and renewals of licenses
  • Followed third party testing with independent laboratories
  • Initiated corrective actions with in-house labs
  • Worked with marketing and validation team for products
  • New products: For example, we launched capsulation of a combination of Ampicillin and Cloxacillin for which we needed validation done as very few manufacturers were there for this combination
  • Process control and post-pack audits
  • To check for any defects and filter any probable DoAs going to the end user.

Quality Technician

National DyeChem Industries
01.1984 - 01.1994
  • Responsible for controlling quality during marketing of top quality textile chemicals and dyes
  • All outbound goods will be checked and analyzed in laboratory using various chemical analysis methods as per customer’s specifications
  • Mostly all customized to order chemicals processed through our office
  • Interfacing with various customers for sales and technical services
  • Achieved a major overhaul of quality systems management models in this firm.

Production Foreman

Amar Dye-Chem Ltd
01.1978 - 01.1984
  • Customized to order chemical and intermediates analyzed and supervised
  • Worked with various research teams and pilot prototype compounds of various configurations of Dyes and Chemicals
  • Daily worked with senior Quality team in monitoring of yields, cycle time, on time delivery
  • Achieved considerable improvement in yield by using constant data generated during analysis.

Education

IPC/WHMA-A-620 Specialist - Cable & Wire Harness Assemblies

IPC / Celestica
03.2024

IPC-A-610 Specialist - Printed Circuit Board Assemblies

IPC / Celestica
03.2024

Quality Technician -

ASQ Toronto / Celestica
03.2001

Cost Accounting -

Durham College / Celestica
02.2000

Pharmaceutical MBA -

Bombay Institute of Technology
03.1987

Textile Engineering -

Wet Processing Textile Engineering Diploma
01.1984

Chemistry - Chemical And Physical Sciences

University of Bombay
06.1978

Skills

  • Product Safety (ESD & FOD compliance)
  • Documentation Review
  • Transportation Regulations
  • Food Safety Regulations
  • Aviation Regulations for Maintenance and Overhaul
  • Aviation Regulations for Manufacturing
  • Special Process Audits
  • Internal Audits
  • 8D CAR system
  • Training Oversee
  • Risk Management
  • Regulatory Policies

Accomplishments

  • Achieved AS9100D/AS9110C / ISO 9001 CERTIFICATES as an auditee with pre audit preparation and efficiency.
  • Achieved QMS for Celestica Mississauga by completing procedures, document retention requirements, risk assessments, SWOT analysis, management reviews and internal audits.
  • Achieved successful audits for Transport Canada, FAA, Airbus, Boeing etc to ensure our site is approved for manufacture and repairs.
  • Successfully audited sub contractors for MRO and also helped our sister sites in Mexico achieve certifications.
  • Successfully closed several 8DCARS, improvement projects directed by our customer Honeywell.

Affiliation

ASQ (American society for Quality)

Skills Roles

  • Effective communication with various internal / external customers
  • Quality Audit of incoming material
  • Quality Control of production lines
  • Current Good Manufacturing Practises and GMP audits
  • Statistical Process Control methods
  • Root Cause investigation
  • Failure Reporting Analysis
  • Corrective Action
  • 8D Corrective action procedure
  • Non-Conforming material review board
  • Validation of new products
  • Lean ,Six Sigma (DMAIC), FMEA methods applications
  • Design for excellence (DFX) and Design for Six Sigma (DFSS)
  • Collaboration with customer on continuous improvements
  • Post pack audit & First article inspection
  • MS – Windows, Word, Excel, Power Point
  • SAP, Citrix, Matrix, Oracle use
  • Product specification and validation
  • Query and data reporting / analysis
  • Technical Documentation / Instruction / Manual writing
  • Scheduling and Planning of internal audits
  • Keeping plant ISO / TL ready
  • SQDCM and Lean Applications

References

Will be provided on request.

Languages

English
Full Professional

Timeline

Quality and Regulatory Specialist Manager

Celestica Mississauga (Honeywell Integration)
03.2014 - Current

Quality Engineering Technical Support

Celestica International Inc.
01.1998 - 03.2014

Quality Control

Excel Pharmaceuticals Pvt Ltd
01.1994 - 01.1998

Quality Technician

National DyeChem Industries
01.1984 - 01.1994

Production Foreman

Amar Dye-Chem Ltd
01.1978 - 01.1984

IPC/WHMA-A-620 Specialist - Cable & Wire Harness Assemblies

IPC / Celestica

IPC-A-610 Specialist - Printed Circuit Board Assemblies

IPC / Celestica

Quality Technician -

ASQ Toronto / Celestica

Cost Accounting -

Durham College / Celestica

Pharmaceutical MBA -

Bombay Institute of Technology

Textile Engineering -

Wet Processing Textile Engineering Diploma

Chemistry - Chemical And Physical Sciences

University of Bombay

Similar Profiles

CREATE PROFILE
Aresh Gutta