Represent Quality - as part of a cross functional team ensure delivery of projects (transfers and new technology) into production with the highest level of quality, compliance, and adherence to timelines.
Compile and execute validation protocols for new product/processes and software.
Ensure correct implementation as per standard validation procedures.
Re-validate as required due to engineering change, deviation analysis or upgrade in systems and material.
Use of statistical analysis as part of validation activity and defining subsequent inspection and controls in production.
Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity.
Liase with R & D to ensure Critical to Quality Characteristics are agreed and documented for all Product transfers.
Lead Design for Inspection activities for all Product transfers to ensure latest technology is available to reduce Human Error.
Lead QA input to Design for Manufacture activities on site.
Ensure daily and project compliance with all Documented Quality systems i.e. FDA QSRs and ISO 13485/9001 requirements etc.
Provide technical assistance to carry out problem analysis/complaint investigation as required and define through negotiation effective corrective actions.
Assist in problem solving for new products and established production process enabling reduction in compliance risks, scrap and reprocessing.
Assist in developing, reviewing and approving product, gauge, tooling and fixturing drawings.
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Report issues to the Client and management to ensure appropriate closure.
Maintain and present self and team matrices to Client and TCS management in structured and timely manner.
Performs other duties assigned as needed.
Your Profile
Essential skills/knowledge/experience:
University Bachelors (or equivalent) degree in Engineering (Manufacturing/Mechanical/Production Engineering) is required. Other Advanced degree or a degree with a focus in Science, Computer Science, or digital area may be acceptable.
Strong experience in a regulated industry (MedTech or Pharmaceutical/ Medicine) with experience in Quality Engineering.
Proven ability to successfully introduce new products in the Medical Device Industry.
Experience and a proven track record of implementing appropriate risk mitigation
Experience in Process Mapping, Equipment Qualification and Test Method Validation, Capital Evaluation projects, Final Acceptance, Change Management, Nonconformance.
Understanding of the regulatory requirements for a commercial release (MDSAP, MDD, MDR, FDA, and ISO standards)
In-depth knowledge of Product/Process Risk Management
Prior experience in Process / Manufacturing Quality is an asset.
Prior experience with GD&T, Six Sigma, Lean Manufacturing, Continuous Improvement, Project Management is an asset.
Experience in Product/Process Transfer, Defining Business Requirements, System Integration/Enhancement, Product and Process verification and Validation.
Strong communication, teamwork, problem solving and decision-making skills
Hands on Experience on PLM process.
Proficient with MS Office applications such as MS Word, PowerPoint, Excel.
* Free services are subject to limitations
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