Manager of Quality Systems and Compliance
MAIN PURPOSE OF JOB
The Quality Systems Manager leads and supports the development and implementation of the site quality system and compliance programs. In addition, this person will develop the site compliance program, in collaboration with the Corporate Director of Compliance, which will assure all aspects of the site’s Quality System are in conformance with customer, international and domestic requirements.
- Directs the site level validation and implementation of the Viant Quality Management System (VQMS); develop, improve and implement key quality system processes
- This program will include an assessment of the current state, plans to improve, and monitor and report on progress. In addition, this program will include limited regulatory affairs compliance, such as facility and device registration with FDA and compliance with other regulations, such as JPAL, ANVISA, EU, etc.
- Ensures the development, communication, implementation and maintenance of best-in-class quality management principles and tools
- Promotes continuous improvement
- Defines, communicates and gains cross-functional support for the site’s Quality System and compliance strategy to mitigate product and compliance risk
- Develops cross-functional collaborative relationships to facilitate engagement, team building, best-practice sharing, critical thinking and innovative problem solving
- Assures compliance to any Corporate Quality System policies and procedures to ensure compliance with the applicable domestic and international regulations/standards, as well as Viant corporate policies
- Designs and implements effective quality processes including procedures, documentation systems, CAPA, complaints, tools, reporting metrics and measurable improvements that are required to meet quality system standards and customer requirements
- In collaboration with site HR, assures an effective Quality System Training program for all related procedures/processes is in place and assure training is implemented and effective
- Serves as the deputy Quality Management Representative and work with the site quality director to assure that an effective corporate management review procedure and that an effective management review process is implemented
- Coordinates and manages the site CAPA Review Board to assure the relevant local, or corporate, CAPA process is implemented and effective
- Provides direct compliance support during FDA and other regulatory compliance inspections
- Leads or assists in the formulation and execution of remediation efforts resulting from compliance inspections, FDA Mock Audits, including responses and implementation follow up
- Regularly monitors related internal/external audit results and supplier performance to identify potential high risk suppliers and implement necessary actions to mitigate compliance and product risk
- Responsible for developing and managing the site’s internal audit process, in conjunction with site quality leader. This includes the process for planning Internal audits and tracking/trending audit results; consisting of developing and monitoring audit schedules, execution of audits, review and issuance of audit report documentation and determining adequacy of corrective actions resulting from audit findings and report to Senior Management.
- This will include the planning and implementation of FDA Mock audits and remediation activities.
- Bachelor’s degree in technical or scientific field or equivalent work experience
- 5-7 plus years’ experience in Quality System and Compliance environment.
- Experience in Medical Device manufacturing is required
- Experience with application of FDA and ISO quality standards in a government regulated healthcare industry
- Experience with FDA (or Notified Body) inspections preferred.
- Ability to quickly grasp technology, medical applications, and applicable regulations/standards
- Ability to create and effectively communicate regulations/standards
- Ability to positively influence groups across an organization to embrace a common philosophy
- Ability to manage and execute on multiple, critical projects simultaneously
- Strong ethics to escalate issues in the face of competing corporate priorities
- Ability to develop high performing leaders and teams with a vigor and passion for learning and exceeding the customer’s expectations
- Act as coach, mentor and take responsibility to train and develop staff
- Knowledgeable in regulatory affairs such as compliance with facility and device registration with FDA and compliance with other regulations, such as JPAL, AVISA, EU, etc. is desirable
- Certified for Lead Auditor, Internal/External Audits is desirable
- Up to 25% travel domestically and some international
- Work in an office environment with varying amounts of walking, sitting, standing, twisting, and turning.
- Periodically lift or carry up to 25 lb.
- No unusual or excessive physical demands.
At Viant, we focus on providing end-to-end solutions for medical device OEMs. Our deep materials expertise—combined with our experience in engineering, manufacturing, assembly, packaging, and sterilization—allows us to bring our customers’ healthcare solutions to market. We have facilities across the U.S. and around the world, including low-cost facilities in Costa Rica, China, Mexico, and Puerto Rico. Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.