Quality Engineering Manager

This position is responsible for developing, implementing and maintaining a design and development program in compliance with corporate policies and the requirements of the quality management system.

• Maintain and continuously improve the design and development elements of our quality management system and ensure that processes remain in compliance with company policies and other regulatory requirements as applicable.
• Establish and monitor staff performance and development goals, assigns accountabilities, sets objectives, establish priorities, and provide continuous feedback and recognition on performance.
• Promote a culture of high performance and continuous improvement that values learning and a commitment to quality.
• Manage quality engineering team responsible for providing design control guidance and support for new product introductions and significant design changes.
• Develop, implement and maintain SOPs for the documentation and execution of the company’s Design Control program.
• Manage and participate in product development and product enhancement activities.
• Contribute to the development of hardware, software and assay requirements and specifications for new products.
• Work with cross-departmental teams to support the design, development, integration, transfer, production and after sales support of MSD software, instrumentation, associated test kits, consumables and reagents.
• Specific duties may vary depending upon departmental requirements.

• Bachelor’s degree in Biology, Chemistry, Biochemistry (or other Life Sciences) or Engineering is required.
• Minimum of eight years of experience in a quality role supporting design control activities for multiple or complex product types e.g. software, consumables, instruments is required.
• Experience working with FDA and/or ISO auditors is preferred.
• Minimum of 2 years of management experience required.
• ASQ certification (CQE, CRE, CQA) is strongly preferred.

• Strong knowledge of ISO 13485 and ISO 9001 required.
• Advanced level knowledge of design control processes and best practices.
• Track record of successfully mentoring design and development teams with varying levels of knowledge and experience.
• Strong logical problem solving skills and demonstrated ability to organize and move project tasks forward in an orderly and structured fashion.
• Leadership skills with demonstrated knowledge and understanding of staff management practices and processes and the ability to establish accountabilities and expectations and manage performance to achieve results.
• Strong business acumen, negotiation and mediation skills, as well as a demonstrated attention to detail and a focus on achieving quality outcomes. Ability to build/foster relationships.
• Excellent oral, written communication and interpersonal skills.
• Able to effectively communicate issues/problems and results that impact timelines, accuracy and reliability of data.
• Proficiency in MS Office Suite.
• A wide degree of creativity and latitude is expected including the ability to multi-task and work productively in a demanding production environment with changing priorities.

• This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office.
• While performing the duties of this job, the individual is frequently required to sit and stand for long periods. The individual is occasionally required to walk; use hands and fingers to operate, handle, or feel objects, tools, or controls; reach with hands and arms.

This position performs duties in a standard office environment.

The annual base salary for this position ranges…