Senior Quality Specialist
Senior Quality Specialist leads and directs the execution of the Quality Management System at Align Moscow R&D site to ensure compliance with regulatory requirements along with Align business strategy; serves as the site Quality Leader providing oversight, training and mentoring to the organization in quality matters, supports Software development, SQA and IT teams. He/She serves as the Site Quality Management Representative, leads and participates in Align-wide quality projects and initiatives.
The Senior Quality Specialist maintains all quality related policies and procedures on an ongoing basis to ensure regulatory compliance and to adhere to highest quality standards. He/she reviews the adequacy and effectiveness of the Quality System procedures by doing the following:
- Manages the Quality Management System (QMS) for Align Moscow site and controls QMS documentation
- Maintains all documentation of quality audits, inspection records, countermeasures, and other related documentation
- Monitors regulatory compliance and adequacy of SDLC design control procedures to ensure continuous improvement in quality management process
- Applies modern quality tools for analyzing data to evaluate current processes and recommended adequate changes in processes
- Manages the management review process
- Higher Education Degree in Engineering, Computer Science or equivalent.
- Strong knowledge base of quality audit processes and expectations
- Working knowledge of ISO 9001 standard; ISO 13485 and/or ISO 62304 is a plus
- Minimum of 3 years of related experience and/or training, preferably in Software/IT or medical device industry.
- Ability to lead cross-functional matrix teams.
- Proven track record spanning Software Development and Quality Engineering; medical device industry experience is a plus.
- Strong working knowledge of Risk Management practices.
- Strong problem solving skills.
- Fluent English.
- Proven success in driving cultural change and being a change agent.
We are an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We also respect your privacy. Our Applicant Privacy Policies can be found here: http://jobs.jobvite.com/align-tech/
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