Senior Quality Engineer
Posted on Jun 25, 2019 by TE Connectivity
TE's Medical business unit, part of the Industrial Solutions segment, offers medical device OEMs, a complete product offering, and capability portfolio for minimally invasive, imaging, surgical, diagnostic, and therapeutic devices. With more than 350 design engineers and a global presence in all key medical device hubs, we are a premier partner to the world's leading medical technology companies for their next-generation medical devices. We are experts in all aspects of device design and manufacture, from access & delivery solutions for interventional medicine; to sensors & connectors for surgical applications. Our innovative solutions enable ground breaking medical therapies such as treating heart disease without opening the body, placing microscopic devices into brain arteries and powering robotic surgery.
The senior quality engineer will focus on one of TE Medical's 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.
- 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.
- Establishing and maintaining FMEA's.
- Preparing and updating Operations procedures and associated documentation.
- Reporting area of responsibility metrics.
- Supporting customer and surveillance accreditation audits.
- The Senior 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.
- Performing an active role in further development and continuous improvement of the quality management system.
- Will assist in issues related to Metrology, Inspection, Testing, Product stability, and vendor certification programs.
- Will lead and manage the Material Board to ensure products are appropriately dispositioned within time requirements
- 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.
- Work with suppliers of both raw materials and components, to improve product quality and/or resolve quality issues.
- Perform Supplier Quality Audits as necessary.
- 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.
- BS/BA degree with a scientific emphasis required
- Min. 5 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.
What TE Connectivity Offers
We offer a competitive "total rewards" compensation. Our commitment to our associates includes offering benefit programs that are comprehensive, competitive, and meets the needs of our employees.
- Generous 401(k) Plan
- 100% Tuition Reimbursement
- Benefits start on day one
- Charity Donation Matching Program
- Competitive Paid Time Off
- Employee Resource Groups
- Employee Stock Purchase Program
- Healthcare for Associates and Families
- Health and Wellness Incentives
- Life Insurance and Disability Protection
Throughout our Global reach and various Business Units, we take a balanced approach to the benefits we provide. Many benefits are company-paid, while others are available through associate contribution. Specific benefit offerings can vary by location.