Senior Quality Engineer, Technology Transfer (Medical Device)
- Expired: September 15, 2021. Applications are no longer accepted.
- Job Title: Senior Quality Engineer, Technology Transfer
- Company Name: Biomerics NLE
- Location: Monroe, CT
- Position Type: Full-Time
- Pay: Salary DOE
Position Summary: Biomerics is a world-class contract manufacturer specializing in the design, development, and production of medical devices. The Biomerics NLE (BNLE) division provides full-service metal processing to the interventional and surgical medical device markets.
The BNLE Technology Transfer team is seeking a passionate Senior Quality Engineer to join us in Monroe, CT. Are you: excited to create medical products for our wide range of customers, comfortable in a fast-paced environment, and proud that your efforts ultimately lead to improved quality of life for patients? If so, we would love to meet you.
The right candidate will be passionate about taking critical medical devices and components from the design stage through full production. The Senior Quality Engineer is a high-level resource responsible for creating, transferring, and otherwise implementing processes to ensure the highest levels of quality. Typical tasks include the creation and execution of validation protocols, understanding and documenting customer requirements, determination of sampling plans, ensuring product traceability, and leading troubleshooting and root cause analyses. The right Sr. QE will function as a very active member of a high-performing team.
- Develops and sustains required quality procedures and controls to ensure that critical requirements are engineered into product development and manufacturing processes.
- Identifies and mitigates risks.
- Create test protocols, runs experiments, and writes test reports.
- Ensures all documentation and systems are in place at launch in accordance with appropriate regulations and requirements.
- Interacts with customers collaboratively to exceed expectations.
- Expert at conceptualizing and implementing quality control systems.
- Understands potentially complex interactions between protocols, procedures, work instructions, and controls.
- Proficient with a variety of common medical device manufacturing approaches.
- Proficient with the requirements of medical device design controls.
- Proficient with statistics.
- Analyzes and solves problems.
- Proficient with root cause analysis and corrective/preventive action procedures.
- Experience in interacting with all functions within a business.
- Experience in clinical and/or pre-clinical settings is a plus.
- Communicates well. Interacts with customers. Effectively presents materials.
- Knowledgeable of and works within FDA, MDR, ISO, IEC 60601, and other relevant regulations and standards.
- Bachelor's Degree in Mechanical Engineering or equivalent with 10+ years medical device manufacturing industry experience, Master's degree in Engineering with 8+ years industry experience.
- Thorough understanding of medical device manufacturing, especially as it relates to FDA (cGMP) manufacturing requirements.
- Passing a background check, which may include verification of prior employment, criminal conviction, educational and driving records.
- Domestic and international travel will be required
- Bilingual in Spanish is a plus!
Benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, 401k
Please, No Recruitment Agency calls or emails (we are not using recruitment services for this or any other role posted).
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