Proficient in risk management practices and tools, having high expertise in failure modes associated with production and production related processes, (PFMEA).
Support the Risk Management File through risk Management Principles. Responsible for the evaluation of process risks, risk mitigation and ensures appropriate production and process controls are identified, qualified, and implemented throughout the product manufacturing lifecycle (at supplier, incoming of materials/components, manufacturing, until product release) through robust pFMEA.
Influence processes towards validation versus manual verification, where possible. Support Sterilization validation activity, as required
Apply appropriate statistical techniques to ensure the development of robust, predictive quality systems which are easily transferable and maintainable in a production environment.
Provide expertise for NC’s & CAPA’s related to new products. Act as a subject matter expert and mentor in problem solving and root causing tools.
Support Design for Manufacture and Assembly (DFMA) through process design, inspection optimization, application of state-of-the-art technologies and tooling & fixture development.
Lead the supplier qualification strategy and approve the supplier validations and Production Part Approval Process (PPAP). Ensure Supplier’s Quality Systems can complete process characterization and develop highly capable processes that are scalable, and meet Stryker expectations.
Provide Quality input to influence the proper selection of suppliers.Support implementation of supplier certification . Support Supplier Quality to establish Quality Agreements with Stryker sites and suppliers as part of NPI projects.
Represent quality assurance during the DTAP (Design Transfer Agreement Plan) process, ensuring product launches meet or exceed established metric targets including supplier DPM, right first time, manufacturing loss, manufacturing complaints per million, units recalled, product escapes and use-as-is, in conjunction with other targets per the DTAP. Represent NPI Quality Assurance at Design reviews and ensure integrity of the process design through robust NPI quality deliverable
Provide subject matter expertise in Design transfer processes and procedures, participating and interfacing in internal & external audits with regulatory representatives.
What You Need:
Must have
Bachelor of Science, Engineering or related subject in Electrical/Electronics/Mechanical with 2- 5 years’ experience in APQP, New Product development, PPAP and Design Transfers.
Analytical & problem solving skills, process improvement orientation, and the ability to handle multiple tasks.
Competency in Metrology including ability to interpret complex engineering drawings and understand geometrical dimensioning and tolerance. Knowledge in selection & development of inspection techniques – automated inspection techniques such as CMM and vision systems a plus.
Working knowledge/experience of risk based and statistical techniques, in particular process risk, failure mode and effect analysis (FMEA), statistical sampling plans, process capability and MSA’s.
Preferred
Previous experience in a regulated environment within a manufacturing environment required (medical device, pharma, aerospace, automotive). Atleast 2-4 years’ experience in new product/process and/or supplier quality is desired.
Candidate working on OEM NPI Team would be desirable. ASQ CQE, CSQP or equivalent course work / experience desirable
Proficient in understanding of Medical Device manufacturing processes desirable.Familiarity with ISO 13485, QSR, GDP, GMP desirable.
Lean Six Sigma training has a distinct advantage.Highly proficient in all aspects of Validation. Computer System validation will be a distinct advantage.
Experience in executing complex problem-solving and process improvements techniques related to design/process/technical issues using lean six sigma tools like DMAIC.
