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 world’s most respected names in medical technology, they help develop and manufacture devices that save, sustain, and transform lives. It’s important work, and not just anyone can do it. Every single person who works there plays an essential part. And we’re delighted you’re interested in joining their team.
As a Quality Engineer, you will balance your talents in quality engineering, and a knowledge of the industry’s regulatory guidelines. Your leadership skills will take center stage as you spearhead 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.
- Responsible for leading the investigation of customer complaints and effectively implementing corrective/preventive action.
- Responsible for the timely resolution of complex Quality issues by means of identification of root cause(s).
- Leads continuous improvement and cost improvement projects, typically involving cross-functional teams.
- Implements quality monitoring/reporting activities, including data collection, analysis, and regular issuance of metrics.
- Leads the company’s Material Review Board meetings.
- Acts as the lead auditor for internal audits and key support for customer and regulatory audits.
- Reviews process qualification and validation protocols and reports
- Creates and maintains quality work instructions, inspection plans, and control plans.
- Responsible for conducting software validation on quality related software and inspection and test equipment.
- Acts as the key technical support for complex inspection and tests equipment and systems.
- Responsible for presenting corrective actions to customers, both internal and external.
- Creates and processes engineering change orders, deviations, document changes.
- Evaluates new inspection and test equipment, quality software, and other industry trends.
- Demonstrates the proficient use of engineering principles in problem solving and CI activities.
- Acts as a back-up to the Supplier Development Engineer
EDUCATION + EXPERIENCE
- Bachelor’s degree in engineering or technical degree
- 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 machine’s 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