Senior Medical Quality Engineer
- Lake Oswego, OR
At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.
Are you a self-starter, a go-getter and have a passion for quality design? At TE Connectivity, you will find a culture that rewards such hands-on engineering spirit. We empower our engineers to work collaboratively supporting our customer's medical products. This is a great opportunity to join our team that is seeking a like-minded person to coordinate material compliance declarations, to expand our New Product Integration. draft and execute validations, create and implement SOPs within an ISO-certified quality system and work to positively impact cost of quality improvement projects.
As a Senior Medical Quality Engineer within the Medical Business Unit, this individual will be responsible for completing equipment and process validations among other deliverables for New Product Integration projects, supporting CAPA and internal audit programs, implementing SOPs within the TE Medical QMS for high quality medical products while also being the leading voice of quality and ensuring compliance to the TE Medical QMS requirements and ISO regulatory requirements. This position is for roughly a year duration.
As a Senior Medical Quality Engineer, a typical day may include:
- Establish process metrics to evaluate process/project performance, define control points, and work with engineering and manufacturing to ensure that minimum expectations are met.
- Coordinate with local site resources to complete CAPA and internal audit activities. Provide corresponding metrics to management.
- Draft and execute Product Validation Plans, IQ/OQ/PQ protocols and Test Measurement Validations
- Support and manage the inspection systems at TE-Medical for new and existing products, including product transfers.
- Use structured problem-solving techniques and root cause analysis to resolve product nonconformances, CAPA projects and customer complaint issues
- Support the new product development and product transfers processes including FMEA, Control Plans, and DOE to ensure product meets customer requirements
- Create Quality Inspection Plans for components and assemblies
- Creation and implementation of SOPs and Risk Management documents to ensure product conformance and compliance
- Lead lean projects and process to create efficiencies
What your background should look like:
- Bachelor's degree in materials science, engineering, manufacturing or technical discipline
- 5 years of experience in quality engineering
- Strong understanding of IQ/OQ/PQ medical device qualifications
- Prior experience working within ISO 13485 or 9001 standards or FDA 21 CFR Part 820
- Strong root cause analysis and structured problem-solving skills
- Strong understanding of statistical analysis techniques
- Audit certification in ISO 13485, 9001 or FDA 21 CFR Part 820
- Six Sigma knowledge
- Experience with Power BI and data interface systems for reporting and analysis
- Current knowledge of relevant manufacturing technologies, materials, equipment, and processes
- Experience working in Cleanroom or Controlled Environment manufacturing areas
- Excellent written and oral communication skills
- Familiarity with various types of materials (i.e. resins, metals, electronic components) is desired.
This position is located in Tualatin, OR and will support projects also covering nearby Wilsonville, OR location.
About TE Connectivity
TE Connectivity is a $13 billion 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 nearly 80,000 employees, including more than 8,000 engineers, working alongside customers in approximately 150 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn , Facebook , WeChat and Twitter .
What TE Connectivity offers:
We offer competitive total rewards compensation. Our commitment to our associates includes offering benefit programs that are comprehensive, competitive and will meet the needs of our associates.
- Generous 401(k) Plan
- 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.
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