Quality Engineer I

on assigned areas of manufacturing, supplier management, and process validation.

What will you do?

• ✓Areas of responsibility may include: non-conforming product, CAPA, calibration systems, supplier auditing, sterility assurance, and improving measuring techniques, design of gages, training, statistical support, quality planning, experimental protocols, and facilitation of root cause analysis, risk assessment and complaint investigation.
• ✓Know and follow all laws and policies that apply to one’s job and maintain the highest levels of professionalism, ethics and compliance at all times.
• ✓Communicate and resolve quality issues and apply root cause analysis to drive corrective and preventive actions.
• ✓Work on continuous improvement activities. These may include participating in, and/or leading Quality Improvement Teams.
• ✓Provide quality reports and review trending on assigned areas of responsibility.
• ✓Conduct failure investigations and problem analysis regarding customer complaints, stock evaluations, supplier quality issues, calibration out of tolerance conditions, and CAPAs (internal or audit CAPAs).
• ✓Review and approve documents and drawings for manufacturing and product development (DCOs, MCs).
• ✓Support to Engineering, Manufacturing, Materials, Inspection, Distribution and/or Product Development Groups in order to assure quality and compliance of products.
• ✓Design gauging and develop tools and techniques to measure product parameters to assure product complies with engineering drawings.
• ✓Recommend, acquire and validate the necessary tools, equipment and technologies to support inspection and testing activities.
• ✓Develop and document Quality Plans to support product acceptance activities.
• ✓Facilitate creation of risk management documents.
• ✓Ensure compliance issues are addressed for product activities.
• ✓Participate on design reviews and risk analysis for product changes.
• ✓Provide process validation program oversight to ensure adequacy of validation activities and documentation in terms of regulatory compliance and technical/statistical soundness.
• ✓Review, assess and evaluate validation protocols (IQ, OQ, PQ) for compliance to procedures and regulations, statistical validity and approval.
• ✓Provide guidance to others for the generation of clear, concise and defendable protocols and reports.
• ✓Assist in determination of the need for validation.
• ✓Manage process monitoring activities including tracking, data collection and analysis, corrective action, and reporting.
• ✓Manage supplier validation activities including supplier assessment, protocol development, and generation of supplier validation master plan(s).
• ✓Coordinate and participate on supplier audits and technical assessments.
• ✓Assist purchasing with identification and qualification of suppliers and alternate manufacturing locations.
• ✓Administrate Supplier Management Program and measures effectiveness.
• ✓Manage Supplier CAPA activities including root cause analysis, definition of corrective actions and verification of actions.
• ✓Coordinate Quality Plans and inspection/test methods between suppliers and Synthes.
• ✓Visit suppliers for the purpose of quality issues investigation and capability analysis.
• ✓Assist purchasing in resolution of supplier complaints.

How will you get here?

o A minimum of 1 year (professional, internship, co-op, etc.) experience working in a quality system framework (ISO 9001 or similar).

o Medical device/diagnostic/or pharmaceutical industry experience.

o Knowledge of FDA’s QSR and ISO regulations.

o Working knowledge of Geometric Dimensioning and Tolerancing, Blueprint Reading, Basic Metrology, Gage design, Design/Process FMEA and Quality Plan Development.

o Knowledge of Gage Repeatability and Reproducibility, Statistical Process Control, Process Capability and Design of Experiments.

o ASQ Certified Quality Engineer, Lean Manufacturing and/or Six Sigma certification.

o Knowledge of Manufacturing materials and removal processes (machining, sheet metal, electro polishing, passivation, hard coating, cleaning, adonization, etc.).

o A minimum of a Bachelor’s degree in Sciences, Business, Engineering or related technical field.

o Ability to manage multiple projects/requirements in a fast-paced environment.

o This position will be located in Elmira, NY and may require up to 10% travel including potential international travel.