Quality Engineer I

About the role

This position combines Quality Engineering and Supplier Development responsibilities, focusing on process improvement, corrective actions, and supplier quality management in a high-tech manufacturing environment.

Responsibilities

• Quality Engineering:
  • Lead Material Review Board (MRB) process
  • Lead Continual Improvement (CI) projects for process and part-specific improvements
  • Lead customer complaint investigation and corrective action activities
  • Implement and monitor Statistical Process Control (SPC) on production jobs
  • Develop manufacturing process and software validation protocols and reports
  • Meet Quality Objectives established through business planning
  • Work with cross-functional groups to generate written responses to customer requests for corrective action
  • Use DMAIC Roadmap to lead process improvements
  • Lead internal Quality System audits
  • Update part-specific Quality Work Instructions and Inspection Plans per engineering change order requirements
  • Support Quality Inspectors and Technicians on inspection and test methods and equipment concerns
• Supplier Development:
  • Ensure technical requirements for purchased items or services are clearly identified, communicated, and managed
  • Work with Sr. Buyers/Estimating/Engineering groups to identify sourcing options considering ASL, pricing, timing, technical capabilities, and supplier quality systems
  • Guide the Design for Supplier (DFS) process to develop and manage appropriate specifications (Prints, ISR, Outsource Specifications, Material Specifications, etc.)
  • Establish and monitor incoming receiving plans to ensure supplied materials/services meet specifications
  • Work closely with suppliers to ensure clear understanding of specifications and requirements
  • Monitor performance of supplied materials/services at all stages of the product lifecycle (incoming receiving, development process, PQ runs, ongoing manufacturing)
  • Create and implement key supplier development processes and strategies to achieve expected supplier performance, development, and improvement
  • Develop strategies and scope for various types of supplier audits; conduct supplier audits to ensure alignment with business needs
  • Review and approve quality system audit reports
  • Support Buyers in developing and maintaining strategic supplier partnerships for lowest total cost, highest quality, and superior customer service
  • Develop alternative suppliers for key materials/services based on performance, risk, and business needs
  • Manage supplier quality through corrective actions and lead resolution of supplier-related technical and quality issues
  • Work closely with Sr. Buyers to initiate commercial aspects of supplier relationships when establishing new sources of supply
  • Handle customer inquiries for material purity directives (e.g., RoHS, REACH, Tallow Derivatives) by contacting suppliers for information
  • Work with manufacturing engineering and Business Continuity Managers to explore and implement sourcing changes for cost savings and performance improvements
  • Handle technical-related Supplier Change Notifications (Material/Process Changes)
  • Assess suppliers and potential suppliers for competitive positioning and safeguard confidential information
• General Responsibilities:
  • Protect confidential information and intellectual property
  • Perform other duties as assigned
  • Follow safety requirements as defined in the Safety Manual
  • Provide back-up support for the Senior Quality Manager

Benefits

• Medical insurance
• Dental insurance
• Basic and voluntary life insurance
• Short- and long-term disability insurance
• 401(k) retirement options with company match
• Paid time off and paid holidays
• Annual incentive bonus opportunities
• Flexible spending accounts
• Educational assistance and tuition reimbursement programs

Pay

Salary range: $67,000 to $105,000

Qualifications

• Preferred Qualifications:
  • Bachelor’s degree in engineering or technical field and 8+ years of relevant experience
  • 3+ years of Quality Engineering experience in a medical or other high-tech manufacturing environment
• Other Qualifications and Desired Skills:
  • Solid communication and human relations skills
  • Strong problem-solving and troubleshooting abilities
  • Comprehensive knowledge of Statistical Process Control
  • Comprehensive knowledge of blueprint reading and geometric dimensioning and tolerancing
  • Ability to use inspection equipment such as micrometers, tool scopes, and coordinate measuring machines (CMMs)
  • Basic knowledge of cGMPs, ISO 9001, and ISO 13485
  • ASQ QE certification and Green Belt training desired
  • Experience using quality tools including FMEA, DOE, and capability analysis
  • Knowledge of injection molding processes and equipment, scientific molding methodology, process monitoring systems, and precision machining
  • Knowledge of manufacturing operations such as welding, pad printing, assembly, and bonding
  • Knowledge of thermoplastic, liquid silicone, titanium, stainless steel, and other materials