Quality Engineer - St Paul, United States - Grey Search + Strategy

Grey Search + Strategy St Paul, United States

2 weeks ago

Description

ABOUT THE COMPANY

Our client is a key player in the medical device consulting and manufacturing industry at a time of great innovation and progress in their field.

Partnering with some of the worlds most respected names in medical technology, they help develop and manufacture devices that save, sustain, and transform lives.

Its important work, and not just anyone can do it. Every single person who works there plays an essential part. And were delighted youre interested in joining their team.

ABOUT YOU

As a Quality Engineer, you will balance your talents in quality engineering, and a knowledge of the industrys regulatory guidelines.

You will lead and participate in various projects and processes to meet crucial business and quality objectives, all while uncovering opportunities for improvement along the way.

Your keen attention to detail, crystal clear communication and high standards will help you keep regulations and protocol in check, as well as manage the documentation that keeps your department running smoothly.

You comfortably collaborate with internal and external partners to meet needs and resolve issues. And like all team members, you maintain a constant commitment to professionalism, safety and confidentiality.

KEY RESPONSIBILITIES
Responsible for leading the investigation of customer complaints and effectively implementing corrective/preventive action.
Responsible for implementing and monitoring Statistical Process Control (SPC).
Leads continuous improvement projects, typically involving part-specific improvements.
Develops manufacturing processes and software validation protocols and reporting.
Leads Material Review Board processes.
Acts as the lead auditor for internal audits and key support for customer and regulatory audits.
Reviews process qualification and validation protocols and reports
Leads efforts to meet Quality Objectives established through business planning.
Responsible for working cross-functionally to generate written responses to customer requests for corrective action.
Responsible for updating part specific quality work instructions and inspection plans per engineering change order requirements.
Leads Internal Quality System audits.
Supports quality inspectors and technicians on inspection, test methods, and equipment concerns.
Ensures that the technical requirements for purchased items or services are clearly identified, communicated, and managed.

Guides the Design for Supplier (DFS) process to ensure that appropriate specifications are developed and managed (Prints, ISR, Outsource Specifications, Material Specifications, etc.).

Responsible for conducting supplier audits to ensure that the supply base aligns with the business's needs. Reviews and approve quality system audit reports.

Assess suppliers & potential suppliers for their position as a competitor, implementing and following appropriate guidelines & safeguards to appropriately protect confidential information.

Acts as a back-up to the Quality Manager.

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/high-precision manufacturing environment
ASQ QE certification and Green Belt training preferred.

SKILLS + ATTRIBUTES
Solid communication skills
Strong problem solving and troubleshooting abilities.
Comprehensive knowledge of Statistical Process Control.
Comprehensive knowledge of blueprint reading and geometric dimensioning/tolerance.
Extensive experience using quality tools including FMEA, DOE, and capability analysis
Ability to effectively manage multiple projects/tasks simultaneously
Ability to use inspection equipment, such as micrometers, tool scopes, coordinate measuring machines CMMs.
Comprehensive knowledge of cGMPs, ISO 9001 and ISO 13485
Computer proficiency, using both networked personal computers and electronic hardware utilized to run inspection equipment.
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
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