Key responsibilities:
* 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 QSR’s 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 Bachelor’s (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
* Project management skills
* Hands on Experience on PLM process.
* Proficient with MS Office applications such as MS Word, PowerPoint, Excel.