We are looking for a Quality Engineer to join our client in Cambridge, Ma on a direct hire basis.
The Quality Engineer supports quality and regulatory 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, document control, product design verification & validation, medical device software validation, manufacturing process validation, customer feedback, corrections and removals and corrective and preventive action investigations and implementation.
This person may be called upon to participate in the following areas:
- Design Controls – Support Verification & Validation (test plans, protocols, reports), Incoming Inspection, lot release of engineering, clinical and commercial devices, nonconforming product disposition, review of design documentation to support a test run, calibration and equipment validation (IQ/OQ/PQ)
- Quality Systems – Offer suggestions for continuous improvement for quality system procedures in accordance with 21 CFR 820, ISO 13485 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, investigation to determine root cause, 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 metricsSupplier Management – This person may be called upon to do vendor audits, and interact with vendors surrounding Supplier Corrective Action Requests (SCAR)
- Audits – Participate in internal and external audits as needed
- Training – Maintain training records for personnel
- Document Control – Process ECO’s, maintain Quality Records
- Regulatory – Maintain facility certifications; participate in creating submissions for regulatory agencies to support clinical and commercial products.
- Software – Work with software developers
- May be called upon to guide / manage junior engineers
Qualifications and Experience:
- Requires an engineering B.S. degree. Master’s degree in engineering or MBA a plus.
- Minimum 5 years of experience. Experience in a medical device environment preferable, including capital equipment, statistics, and experience with both design and manufacturing.
- Good communication skills, both written and oral.
- Knowledge of and experience with 21 CFR 820 Quality System Regulation, ISO 14971, ISO 13485 and ISO 60601 requirements a plus
- Possess a high sense of urgency, 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.