Senior Quality Engineer
Reports to: Senior Director of Quality and Regulatory
Overview: The Quality Engineer reports to the Senior Director of Quality and Regulatory and supports quality processes for medical device development and manufacturing. This person handles multiple projects and tasks, from product inception through manufacturing and product launch.
The QE represents Quality on internal and external project teams for both design and manufacturing. This role also supports quality systems, product design verification & validation, medical device software validation, manufacturing process validation, customer feedback, corrections and removals and corrective and preventive action investigations and implementation.
About the Company...
Our client is a clinical stage, Series B funded, medical device company focused on advanced drug delivery and backed by world class strategic investment and corporate partners. They are developing and commercializing a highly innovative needle-free software controlled drug delivery platform technology originally developed at MIT. This technology will transform the delivery of medicines and improve the patient experience. Their aim is to replace all needles and syringes with a safe, silent, painless and smart device and to become the standard for modern drug delivery.
Role and Responsibilities:
*Design Controls – Support Verification & Validation (test plans, protocols, reports), test method validation, Incoming Inspection, lot release of engineering, clinical and commercial devices, nonconforming product disposition, review of design documentation, calibration and equipment validation (IQ/OQ/PQ)
*Quality Systems – Support continuous improvement of quality system procedures in accordance with 21 CFR 820, ISO 13485, EU MDR, MDSAP, and ISO 14971
*Risk Management – Maintain the risk management file for Portal Instruments products throughout their lifecycle
*CAPA – Participate with other team members in all aspects of Corrective and Preventive action process as required, including documentation of CAPA, root cause investigation, and implementation of improvement activities
*Complaint Handling – Participate in complaint processing and trending, and failure investigations as needed
*Management Review – Assist management representative in compiling and trending Management Review metrics
* Supplier Management – Perform vendor audits and interact with vendors surrounding Supplier Corrective Action Requests (SCAR)
*Audits – Conduct and/or participate in internal and external audits as needed
*Software – Work with software team and support software development in compliance with IEC 62304
*May be called upon to guide / manage junior engineers
Required Skills and Experience
*B.S. degree in Engineering, Science, or related discipline required. Master’s degree in engineering or MBA a plus.
*Minimum 5 years of experience. Experience in a medical device environment preferable, including experience with both design and manufacturing.
*Strong working knowledge of 21 CFR 820, ISO 13485, and ISO 14971. Experience developing or modifying Quality Management Systems in accordance with these regulations is desired.
*Knowledge and experience with MDSAP, EU MDR, IEC 62304, and ISO 60601 requirements a plus
*Proven track record in new product development and commercialization, post-launch experience a plus
*Experience working with contract manufacturers and establishing relationships with suppliers is a plus.
*Knowledge of sterilization processes for medical devices a plus
*Good communication skills, both written and oral
*Knowledge of statistical sampling and analysis
*Possess a high sense of urgency, good judgement, creative problem solving, initiative and common sense.
*Present a professional demeanor and demonstrate an ability to work effectively with a diverse group of individuals.
*Must be energetic, work quickly and efficiently with detail and accuracy.
*Must be able to effectively manage multiple priorities in a fast paced and dynamic environment
Our client offers a competitive salary, a comprehensive benefits package, including stock
options, a 401(k) retirement plan, a health and dental plan and a chance to make a
difference in the lives of thousands of patients.