Quality Engineer I

About the role

The Quality Engineer I will develop, implement and maintain Quality System requirements on assigned areas of manufacturing, supplier management, and process validation.

Responsibilities

• Develop, implement and maintain Quality System requirements
• Handle non‑conforming product, CAPA, calibration systems, supplier auditing, sterility assurance, improving measuring techniques, design of gages, training, statistical support, quality planning, experimental protocols, facilitation of root cause analysis, risk assessment and complaint investigation
• Know and follow applicable laws and policies; maintain professionalism, ethics and compliance
• Communicate and resolve quality issues; apply root cause analysis to drive corrective and preventive actions
• Work on continuous improvement activities, including participating in or leading Quality Improvement Teams
• Provide quality reports and review trending on assigned areas
• Conduct failure investigations and problem analysis regarding customer complaints, stock evaluations, supplier quality issues, calibration out‑of‑tolerance conditions, and CAPAs
• Review and approve documents and drawings for manufacturing and product development (DCOs, MCs)
• Support Engineering, Manufacturing, Materials, Inspection, Distribution and/or Product Development Groups to assure product quality and compliance
• Design gauging and develop tools and techniques to measure product parameters to assure compliance with engineering drawings
• Recommend, acquire and validate 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 (regulatory compliance, technical/statistical soundness)
• Review, assess and evaluate validation protocols (IQ, OQ, PQ) for compliance, statistical validity and approval
• Provide guidance for 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
• Administer Supplier Management Program and measure 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 quality issues investigation and capability analysis
• Assist purchasing in resolution of supplier complaints

Requirements

• Minimum of a Bachelor’s degree in Sciences, Business, Engineering or related technical field
• Ability to manage multiple projects/requirements in a fast‑paced environment

Qualifications

• Minimum of 1 year (professional, internship, co‑op, etc.) experience working in a quality system framework (ISO 9001 or similar)
• Medical device/diagnostic/or pharmaceutical industry experience
• Knowledge of FDA’s QSR and ISO regulations
• Working knowledge of Geometric Dimensioning and Tolerancing, Blueprint Reading, Basic Metrology, Gage design, Design/Process FMEA and Quality Plan Development
• Knowledge of Gage Repeatability and Reproducibility, Statistical Process Control, Process Capability and Design of Experiments
• ASQ Certified Quality Engineer, Lean Manufacturing and/or Six Sigma certification (preferred)
• Knowledge of Manufacturing materials and removal processes (machining, sheet metal, electro polishing, passivation, hard coating, cleaning, anodization, etc.)

Skills

Knowledge of Geometric Dimensioning and Tolerancing, Blueprint Reading, Basic Metrology, Gage design, Design/Process FMEA, Quality Plan Development, Gage R&R, SPC, Process Capability, DOE, ASQ CQE, Lean, Six Sigma, manufacturing materials and removal processes.

Benefits

• Medical, dental, and vision insurance plans
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