Quality Assurance Engineer
Quality Assurance Engineer – assist in commercialization of an innovative medical device.
Greater Boston area.
Our Client, is in the exciting stage of transferring a product from R&D to production and is looking for a Quality Assurance Engineer who is hands-on and has a creative approach to addressing quality related functions. This is a mid-level career position for a Quality Engineer to partner with manufacturing operations, take ownership of quality projects and learn and grow with the company. (Note- over one third of all of this company's employees have been with the company for at least 10 years with the majority rising to positions of greater responsibility)
Reporting to the Quality System Manager, in this role, the candidate will focus on assuring company compliance to FDA QSR, ISO 13485, and ISO14971, as well as additional regulatory requirements with a principal focus on suppliers and manufacturing. Supporting the pending commercialization of a new and innovative medical device, your responsibilities will include development of metrics for all areas of the supplier, incoming (MRB and NCMRs), and manufacturing quality and report metric results at Product Reviews.
* Maintains and improves the Supplier Quality Management System to ensure compliance with ISO standards, QSR Regulations and other regulatory requirements and standards.
* Facilitator for material and product nonconformance (NCMR) resolution.
* Assists Engineering and Manufacturing with supplier issues and supplier Corrective Actions.
* Develop and maintain production Quality Control procedures and methods and train QC personnel.
* Work with Engineering and Manufacturing on equipment and process validations and process FMEA's.
* Provide audit support during regulatory body inspections with FDA, TUV, and partners.
* Assist in the qualification, validation, and continued monitoring of ISO Class 7 Clean Rooms.
* Conduct internal audits of Quality System and critical/key supplier audits.
* Facilitate and manage equipment calibration using an outside supplier.
* Assist in the training of personnel on the Quality System and help maintain the training system.
* Collaborate with department/system SME's to develop and/or revise existing procedures (OPs, OIs, work instructions) to ensure documentation is compliant to the Internal Quality System and external regulatory requirements.
* Facilitate product complaint investigation in coordination with product development and manufacturing.
* Other additional responsibilities as deemed by management to support the Quality Assurance and Regulatory requirements.
* BS Degree in Life Sciences, Engineering, or related discipline. MS degree a plus.
* Strong writing, communication, leadership, and presentation skills.
* Six Sigma Green or Black Belt is a plus.
* ISO 13485 Lead Auditor experience is a plus.
* A minimum of 3 years medical device experience in Quality Assurance, or Quality Control (Must have)
* Previous experience working in an FDA, and/or notified body regulated company.
* Previous experience with implantable medical devices is a plus.
* Manufacturing engineering experience a plus.
* Clean Room experience a plus.
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