Senior Manager of Quality Assurance
The Senior Manager of Quality Assurance will lead, establish, implement and maintain quality assurance systems and activities ensuring compliance with domestic and international quality system standards and regulations for commercial medical devices designed, produced and marketed by Nanosphere. The individual will also provide technical and organizational leadership to Quality / Quality Assurance activities and expand the Quality Assurance function by providing value-added services to the company. Partners with Manufacturing, Design/Development, Systems Engineering, Quality Control and others cross functionally to deliver the highest quality products. The individual must be a strategic thinker, good communicator and possess the ability to inspire and lead others.LOCATION
• Responsible for the strategy, administration, and direction of the Quality Assurance organization. Directs all aspects of Quality Assurance, using a well-grounded understanding of technical, scientific and regulatory issues.
• Monitors the Quality Management System (QMS)
• Directly supervises employees in the Quality Assurance organization.
• Develops, administers, and maintains quality systems required to ensure the company’s products are in compliance with quality standards and regulations.
• Member of the QMT, with responsibility for assigning and monitoring all CAPA activities.
• Functions as an integral member of new product development teams. Responsible for ensuring compliance during the design control and design transfer processes.
• Participates in new product development team meetings, technical design reviews, and phase gate design review meetings to contribute quality assurance requirements and considerations.
• Leads risk management activities throughout the product lifecycle, including new product development and post production risk management.
• Regularly reviews quality system standard operating procedures and work instructions, making changes as necessary to ensure compliance and efficiency Quality Assurance processes.
• Provides input to the Management Review and Quality Review Board processes.
• Responds to nonconformities identified in internal audits, and to corrective / preventive actions assigned to Quality Assurance.
• Responsible for all aspects of regulatory compliance including FDA regulations.
• Participates in FDA inspections.
• Other duties as assigned
• Responsible for responses to inspections, audit and regulatory responses.
• Maintenance of support of the QMS through internal audits, development of procedures, maintenance of quality records and training of office and manufacturing personnel.
• Strong planning, organizing, and communications skills.
• Ability to manage a large volume of information at once, keeping focused on priorities.
• Conscientious, detail orientated character
• Analytical mind set and enjoy working with data and statistical information
• Strong attention to detail with excellent follow-up
• Bachelors Degree in engineering or technical field required. Advanced degree preferred.
• Minimum of 10 years experience in a cGMP environment (ideally in the medical device industry)
• Strong experience and familiarity with product development and manufacturing of products that are highly regulated by the government.
• Management experience in a complex quality assurance / quality systems field.
• Demonstrated knowledge and understanding of the 21CFR Part 820 and ISO 14971:2012 requirements.
• Implement and maintain a quality management system in accordance with ISO 13485
• Ability to provide leadership to others in the organization through influence, innovative practices and coaching skills to foster a corporate culture that of responsiveness, compliance awareness, self-regulation, quality system ownership, challenge of status quo, and continuous improvement in order to achieve the highest level of compliance.
• Excellent problem solving methodology, using industry accepted concepts and tools to solve complex problems in creative and effective ways as they apply to compliance issues.
• Possesses a strong scientific and technical background, sufficient to establish credibility with senior management as well as the manufacturing and product development teams.
• Hands-on ability to sort through technical complexities and work in a flexible changing environment
• Ability to work varied and extended hours/days, as business dictates.
It is impossible to list every requirement for, or responsibility of, any position. Similarly we cannot identify all the skills a position may require since job responsibilities and the Company’s needs may change over time. Therefore, the above job description is not comprehensive or exhaustive. The Company reserves the right to adjust, add to or eliminate any aspect of the above description. The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.
Nanosphere is an Equal Opportunity Employer. It is the policy of Nanosphere, Inc. and its subsidiaries to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, gender, religion, national origin, disability, veteran status, age, marital status, sexual orientation, genetic information or any other protected group status and further, to take affirmative action to employ and advance in employment minorities, women, disabled persons, disabled veterans, recently separated veterans, Armed Forces service medal veterans or other protected veterans.