Quality Engineer I

Quality Engineering Responsibilities

• 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
• Responsible for implementing and monitoring of Statistical Process Control (SPC) on production jobs
• Develop manufacturing process and software validation protocols and reports

• Lead efforts to meet Quality Objectives established through business planning

• Work with cross functional groups to generate a written response to customer’s request 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 Responsibilities

• Primary role is to ensure that the technical requirements for purchased items or services are clearly identified, communicated, and managed. 
• Work in conjunction with the Sr Buyers/Estimating/Engineering groups to identify sourcing options – considering ASL, pricing, timing, technical capabilities, supplier quality systems, etc.
• Guide the Design for Supplier (DFS) process to ensure that appropriate specifications are developed and managed (Prints, ISR, Outsource Specifications, Material Specifications, etc.)
• Ensure that incoming receiving plans are established and monitored to ensure reasonable confidence that supplied materials/services meet established specifications.
• Work closely with suppliers to ensure clear understanding of specifications and requirements.
• Monitor performance of supplied material/services at all stages of the product lifecycle – incoming receiving, development process and PQ runs, ongoing manufacturing.
• Create and implement key supplier development processes, and strategies designed to achieve expected supplier performance, development and improvement.
• Develop a strategy and scope for various types of supplier audits.  Conduct supplier audits to ensure that supply base aligns with business needs.  Review and approve quality system audit reports.
• Work with Buyers in support of developing and maintaining strategic supplier partnerships that will provide competitive advantages in lowest total cost, highest quality, and superior customer service.
• Develop alternative suppliers for each key material/service based on current supplier performance, risk and business needs.
• Manage supplier quality through corrective actions. 
• Lead resolution of supplier-related technical and quality issues.
• Work closely with the Sr. Buyers to initiate the commercial aspects of our supplier relationships when establishing new sources of supply.

• Supply Agreements

• Price & cost drivers
• Supplier relationship management

• Handle customer inquiries for material purity directives (i.e. RoHS, REACH, Tallow Derivates, etc.) by contacting suppliers for information. 
• Work in conjunction with the manufacturing engineering group and Business Continuity Managers to explore and implement sourcing changes – cost savings, performance related.
• Handle technical related Supplier Change Notifications (Material/Process Changes)
• Assess suppliers & potential suppliers for their position as a competitor implementing and following appropriate guidelines & safeguards to appropriately protect confidential information.

General Responsibilities

• Responsibility to 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 and Pay:                                                                                                             

Benefits:

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

Pay:

• Salary range: $67,000 to $105,000

Preferred Qualifications:                                                                                                                                              

Education/Experience:

• Bachelors degree in engineering or technical degree and 8 years of relevant experience
• 3 years 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 blue print reading and geometric dimensioning and tolerance
• Ability to use inspection equipment, such as micrometers, tool scopes, coordinate measuring machines CMM’s
• 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

Salary : $67,000 - $80,000