Sheehan Clint Soans
Böblingen,Baden-Württemberg
Summary
Organised and dependable Product Quality Engineer with 11 years of experience. Successful at managing multiple priorities with positive attitude. Willing to take on greater responsibilities to meet team goals.
Overview
16
16
years of professional experience
7
7
years of post-secondary education
1
1
Certification
Work history
Product Quality Engineer
Philips
Böblingen, Baden-Württemberg
07.2019 - 04.2025
- Supported internal and external audits
- Acted as a quality representative in NPI projects to ensure that product design meets quality and compliance standards for every milestone
- Ensured that appropriate quality plans are made that include all stages of the life cycle of the product
- Supported validation of key design inputs like: usability, reliability, performance, manufacturability, safety, serviceability, sustainability and costs
- Responsible for assessing product designs and reviewing test and other performance data
- Supported CAPA teams with root cause analysis and quality problem-solving
- Provided other quality engineering support, including assisting organizational units in leading resolution of quality engineering deficiencies
- Provided effective oversight of the execution of any Risk Management activities, and of all design-related activities during the product/system lifecycle
- Supported process improvement by providing feedback to respective SMEs
Quality Engineer
EnviteC by Honeywell
Wismar, Mecklenburg-Vorpommern
11.2017 - 06.2019
- Responsible for plant Quality and Regulatory Affairs
- Provide leadership in the implementation and execution of Quality Systems activities execution of the programs and processes related to CAPA, Management Reviews, Supplier Quality Management, (Scars and Inspection) Management Reviews, Non-Conforming and internal audits and training activities, etc
- Supported the facility as a Quality Management System (QMS) Representative
- Coordinated management review periodically to assess the effectiveness and suitability of the quality management system
- Monitored and assessed quality performance to gauge progress
- Development, implementation, and maintenance of quality systems to assure FDA, ISO compliance, MDD Compliance
- Coordinated all facility audits (FDA, ISO, Corporate, Customer) including conducting internal and supplier audits including drafting corrective actions
- Reviewed and approved Engineering changes to products; processes and materials
- Applied problem-solving skills to the corrective and preventative action (CAPA) process to eliminate the problem's root cause(s)
- Supported CFT in NPI projects as a quality representative
- Acted as primary contact concerning all regulatory affairs queries
- Supported in 510(k) submissions
Quality Engineer
QUALIMED Innovative Medizinprodukte GmbH
Winsen
07.2014 - 11.2017
- Responsible for supplier management and complaints management.
- Carried out Supplier Qualification activities such as supplier selection and supplier evaluation
- Worked to resolve supplier quality issues to ensure non-recurrence of non-conformance
- Carried out First Article Inspection
- Supported supplier agreements and change agreements
- Plan and conducted supplier audits
- Maintained the complaints database
- Lead investigation of customer complaints
- Initiates preventive actions based on customer complaints
- Maintain statistics of all the complaints
- Ensuring compliance with appropriate time limits
- Ensure completion of complaint reports
- Training of employees on corrective actions
- General Responsibilities
- Construction and/or revision of procedures as per ISO 13485 and ISO 9001
- Planning of internal audits on regular basis
- Assisted audits from customers and/or notified bodies
- Supported internal CAPA
Intern
Robert Bosch Productiv.N.V
Teinen
05.2012 - 11.2012
- Internship in Development Department
- Tasks: Product testing of windshield wipers, Quality Check, Root Cause Analysis of different pattern of wear observed in Wiper blades, set up of Quality Assurance Methodology
University Project - Student
BMW - Motorad Berlin
Berlin
11.2011 - 02.2012
- Optimization of Production Lines, Value Stream Mapping, Lean Implementation
Trainee Engineer
Bharati Shipzard Ltd
Mumbai, Maharashtra
12.2009 - 06.2010
- Production) - Ship Building
- Tasks: Production planning, Quality Inspection, Quality Check, Inspection of fabricated units at regular intervals to ensure it's as per the technical specification, Welding inspection, Erection of fabricated units/ machinery
Maintenance Engineer
Primacy Industries Pvt. Ltd
Mangalore, Karnataka
12.2008 - 12.2009
- Tasks: Assist Maintenance Team in equipment erection & commissioning
- Ensured smooth and continuous operation of plant & machinery at the optimum level
- Ensured prompt rectification of faults/ breakdowns for continuous production
Education
Master of Science - Manufacturing
Technical University Berlin
Berlin, Land Berlin 10.2010 - 05.2014
Bachelor of Science - Mechanical Engineering
St. Joseph's Engineering College
Mangalore 06.2004 - 05.2008
Languages
English
Advanced
German
Upper intermediate
Affiliations
- Playing musical instruments
- Photography
- Travelling
Certification
- Certified Regulatory Affairs Manager
- Six Sigma Green Belt
- Supplier Management for Medical Device Manufacturers
- MDR Awareness Training
Timeline
Product Quality Engineer
Philips
07.2019 - 04.2025
Quality Engineer
EnviteC by Honeywell
11.2017 - 06.2019
Quality Engineer
QUALIMED Innovative Medizinprodukte GmbH
07.2014 - 11.2017
Intern
Robert Bosch Productiv.N.V
05.2012 - 11.2012
University Project - Student
BMW - Motorad Berlin
11.2011 - 02.2012
Master of Science - Manufacturing
Technical University Berlin
10.2010 - 05.2014
Trainee Engineer
Bharati Shipzard Ltd
12.2009 - 06.2010
Maintenance Engineer
Primacy Industries Pvt. Ltd
12.2008 - 12.2009
Bachelor of Science - Mechanical Engineering
St. Joseph's Engineering College
06.2004 - 05.2008
Similar Profiles
HELEN ELLWOODHELEN ELLWOOD
Commercial Channel Director -Online (Argos Amazon) at PhilipsCommercial Channel Director -Online (Argos Amazon) at Philips
Asim KhanAsim Khan
Director, Product & Portfolio Management at PhilipsDirector, Product & Portfolio Management at Philips
Awijit SinghAwijit Singh
Online Lead ( Head of E-commerce, and D2C ) at PhilipsOnline Lead ( Head of E-commerce, and D2C ) at Philips
Karol MIKULÁŠKarol MIKULÁŠ
Modality Sales Specialist – Enterprise Informatics at PhilipsModality Sales Specialist – Enterprise Informatics at Philips
Nicoletta KarayiannidesNicoletta Karayiannides
English Teacher at Myrsini Educational CentreEnglish Teacher at Myrsini Educational Centre