Quality Engineer II
Medtronic
Summary
The Quality Engineer II will support the Surgical Sutures' Manufacturing business within Medtronic's Surgical Innovations group located in North Haven, CT. This role is integral to ensuring the highest standards of quality and compliance in our medical device manufacturing processes. As a member of our Quality team, you will collaborate cross-functionally to enhance product reliability, optimize processes, and uphold regulatory compliance. This role is 100% onsite at our North Haven, CT manufacturing site.
Job description
Primary Responsibilities
- Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product.
- Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
- Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
- Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
- May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
Required Qualifications
- Bachelor's Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality OR PhD with 0 years relevant experience.
Preferred Qualifications
- Bachelor's degree in Engineering (Chemical, Biomedical, Mechanical, or related discipline); advanced degree preferred.
- Experience working in a fast-paced Manufacturing environment
- Good communication skills, written and verbal
- Work experience in process validation across the full validation lifecycle also IQ, OQ, TMV, PQ
- CAPA (Corrective Action / Preventive Action) experience
- Familiarity with Minitab Statistical Software
- Six Sigma Training
Requirements
- Bachelor's Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality OR PhD with 0 years relevant experience
- Bachelor's degree in Engineering (Chemical, Biomedical, Mechanical, or related discipline); advanced degree preferred
- Experience working in a fast-paced Manufacturing environment
- Good communication skills, written and verbal
- Work experience in process validation across the full validation lifecycle also IQ, OQ, TMV, PQ
- CAPA (Corrective Action / Preventive Action) experience
- Familiarity with Minitab Statistical Software
- Six Sigma Training
Benefits
- Health, Dental & Vision Insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life Insurance
- Long-term Disability Leave
- Dependent Daycare Spending Account
- Tuition Assistance
- 401(k) Matching
- Paid Time Off
- Paid Holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Incentive Plans
Company overview
Medtronic is a global healthcare technology leader and one of the world's largest medical device companies, founded in 1949 in Minneapolis, Minnesota. The company operates in over 150 countries and employs more than 90,000 people worldwide. Medtronic's mission is to alleviate pain, restore health, and extend life through innovative medical technologies. The company develops and manufactures devices and therapies to treat more than 70 health conditions, including cardiac devices, cranial and spine robotics, insulin pumps, surgical tools, patient monitoring systems, and more. With a rich history that began with the invention of the battery-powered pacemaker, Medtronic has grown into a diversified healthcare technology company with four main business units: Minimally Invasive Therapies Group, Diabetes Group, Restorative Therapies Group, and Cardiac and Vascular Group. The company's therapies help approximately 72 million people annually and represent a significant force in advancing medical technology to address some of humanity's most challenging health problems.