Quality Engineer I

Spectrum Plastics Group•New Brighton, MN

8d•$67,000 - $80,000•Onsite

About The Position

The Quality Engineer I will be responsible for leading Material Review Board (MRB) processes, driving Continual Improvement (CI) projects for process and part-specific enhancements, and managing customer complaint investigations and corrective actions. This role involves implementing and monitoring Statistical Process Control (SPC), developing validation protocols, and collaborating with cross-functional teams to address customer requests and meet quality objectives. Additionally, the Quality Engineer will support Quality Inspectors and Technicians, and play a key role in supplier development, ensuring technical requirements for purchased items are met, and managing supplier quality through corrective actions and audits. The position also involves handling customer inquiries regarding material directives and assessing suppliers for competitive positioning and confidentiality safeguards.

Requirements

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
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

Nice To Haves

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

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
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.
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.
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