The Senior Quality Assurance Leader will have quality oversight over development and manufacturing activities for In Vitro Diagnostics (IVD) products. This position is a unique opportunity to develop the quality processes and infrastructure required to deliver IVD products to the international market, so that development and manufacturing requirements are met for new and existing products, including but not limited to manufacturing specifications, design transfer and process validation, and quality system documentation. This individual is responsible providing technical expertise, and teaching and coaching others on IVD and MD quality requirements.
- Assure that the site has policies, processes and procedures in place so that site activities, with regards to design control, process validation and on-market change control, to meet applicable quality and regulatory standards.
- Support, lead and sponsor improvement initiatives; identify and implement change, validation and design process quality improvements.
- Supports the development, manufacture and delivery of quality and compliant products on time, in full and cost effectively to meet the needs of the business and customers
- Works closely with the Technical, Engineering, and Research & Development functions in order to ensure changed or new product/processes are implemented in compliance with Site, Corporate and cGMP requirements, and in a timely manner to ensure business goals are met.
- Responsible for QA oversight, documentation review and product disposition. Ensures non-conforming product is identified and appropriately controlled, and conforming product is appropriately dispositioned for use. Reviews and provides guidance for various non-conforming situations and investigation activities, evaluates root cause and corrective actions, and ensures documentation is complete and accurate.
- Defines and implements Quality System documentation, including Production Batch Records / DHRs, nonconformances, CAPA and associated investigations, and appropriately dispositions affected materials. Performs disposition of manufactured lots, assuring product quality is in compliance with Quality System regulations.
- Assists in the auditing of manufacturing activities and Internal Audits. Provides guidance for investigations of discrepancies or failures related to manufacturing and control systems.
- Participates in project work and initiatives associated with Quality System issues in conformance to regulatory requirements. Interfaces and provides Compliance guidance/support to Operations and Development functions. Participates in the design and implementation of Quality improvement activities.
- Leads site validation and design quality engineering activities to provide a Quality Assurance service to the site, including guidance on validation and design control strategies, guidance on product, process, equipment changes, which may or may not require a design change and/or re-validation.
- Maintain the metrics required to monitor the compliance of the change, validation, and design control processes, escalate issues when necessary Act as a Subject Matter Expert (SME) for application of statistical sampling plans, Design of Experiments (DOE) and design and process failure modes and effects analysis (FMEA). Act as a Subject Matter Expert (SME) for change, validation and design control processes during internal and external Quality System audits.
- Implement an electronic quality management system
- Other tasks as required by the business.
Required Knowledge/Skills, Education, and Experience
BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas. A degree in a technical discipline ensures a basic understanding of the chemistry and principles of the products that are manufactured at the site.
Demonstrates and applies a broad knowledge of field of specialization through successful completion of moderately complex assignments. Successfully applies complex knowledge of fundamental concepts, practices, and procedures of particular area of specialization. Demonstrates knowledge of organization's business practices and issues.
Prior successful demonstration of:
- Validation and design control system experience (5+ years) to lead cross-functionally. Knowledge required of regulations and standards affecting in-vitro diagnostics (IVD) and medical devices (MD), such as FDA QS Regulations Part 820 & Part 11, ISO13485, ISO14971 and cGMP required for maintaining validation and design control compliance.
- Quality Management (5+ years) required to understand and promote Quality standards.
- Project Management (3+ years) required to manage group activities.
- The ability to work effectively across a matrixed organizational structure and be a team player is a key requirement. Agile and flexible team player.
- Able to effectively manage short term and long-term deadlines.
- The incumbent needs to have excellent written, negotiation and oral communication skills. Excellent working knowledge of English grammar and punctuation.
- The incumbent needs to be receptive to change and be able to drive change.
- Any formal certification in the area of cGMP, Quality management, and/or design/validation is highly desirable.
- Experience with Molecular Diagnostics is highly desirable.
HP Inc. is EEO F/M/Protected Veteran/ Individual with Disabilities.