Staff Quality Engineer
Job Type: Full time
At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.
The Staff Quality Engineer will focus on one of TE Connectivity - Medical value streams, working with manufacturing teams to sustain and improve manufacturing quality on Class II and III medical devices. You'll utilize your statistical strengths in SPC-implementation projects, increase efficiencies using continuous improvement methods, and interact with the customers frequently.
- Performing an active role in further development and continuous improvement of the quality management system through identified initiatives, focusing on more mid-term/long-term projects as opposed to day-to-day tactical production line support.
- Investigation of root cause and following through on effective corrective actions to prevent re-occurrence for the customer and internal quality issues.
- Establishing inspection standards, plans, frequencies and test methods.
- Preparing and updating Operations procedures and associated documentation.
- Supporting customer and surveillance accreditation audits.
- The Staff Quality Engineer will perform an active role in quality planning and new product introduction from a quality perspective.
- Maintain relevant documentation to comply with quality standards and customer requirements.
- Quality review of responsible area validation documentation.
- Participates as a key member of new product development core teams, to help ensure that new product quality plans (validation plans, raw/component material specifications, etc.) and risk management files are appropriately established.
- Will assist and train associates in concepts of probability and statistics.
- Design and develop forms and instructions for recording, evaluating, and reporting quality data.
- Investigate and implement corrective and preventive actions (CAPAs) to meet business and compliance requirements.
- Assist with the development and maintenance of the company-wide validation programs.
- Reports verbally and in writing to the Director / Manager regarding the progress and results of projects.
- Participates with the Director / Manager in the preparation of divisional, departmental, and project goals.
- Assists the Director / Manager in presentations of technical nature when requested.
- Ensure that every product and service we supply conforms to FDA and Quality System Regulations as well as EN46001/ISO13485/MDD Standards.
What your background should look like:
- BS/BA degree with a scientific emphasis required
- Min. 8 years' experience as quality engineer
- Good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements.
- ASQ Certified Quality Engineer preferred
- Six Sigma Green/Black belt preferred
- Quality experience in component and device manufacturing preferred.
- Excellent written and oral communication skills essential.
ABOUT TE CONNECTIVITY
TE Connectivity is a global industrial technology leader creating a safer, sustainable, productive and connected future. Our broad range of connectivity and sensor solutions, proven in the harshest environments, enable advancements in transportation, industrial applications, medical technology, energy, data communications and the home. With approximately 80,000 employees, including more than 7,500 engineers, working alongside customers in approximately 140 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn, Facebook, WeChat and Twitter.
- Competitive base salary commensurate with experience: $104,800
- Posted salary ranges are made in good faith. TE Connectivity reserves the right to adjust ranges depending on the experience/qualification of the selected candidate as well as internal and external equity.
- Total Compensation = Base Salary + Incentive(s) + Benefits
- A comprehensive benefits package including health insurance, 401(k), disability, life insurance, employee stock purchase plan, paid time off and voluntary benefits.
EOE, Including Disability/Vets