The position of Staff Engineer QA will have responsibilities aligned to the Product Commercialization Process (PCP). This is an exciting position linked to new product development and commercialization. This role will specifically work on the review of documents and projects supporting new products. There will a strong emphasis on Design History File creation and maintenance. This position can also be characterized as a Design Compliance position.
This role will focus on equipment and software product types.
This role will operate in a matrix environment and will support site operations quality staff, general operations staff, Research & Development staff, and commercial organizations.
- Bi-Lingual (necessary to be English speaking/writing)
- Experience in the development of new products
- Understanding of the creation and maintenance of Design history Files.
- Strong Communication skills.
- Capable of working in a matrix including team members from other global locations.
- Maintain awareness of applicable standards and regulations, and monitor activities related to change to the standards and regulation.
- Stay abreast of all upcoming changes to Product Safety and Compliance regulations and standards to ensure the organization is meeting all current requirements for new and legacy products.
- Assess product regulations and standards impact to meet global requirements
- Provide leadership to sites to ensure global product compliance requirements are understood.
- Advise Divisional and BU leadership teams regarding strategies related to new and changing regulations and standards, including assessment of business compliance risk
- Work closely with new product introduction teams to meet compliance requirements on schedule
- Ensure all necessary compliance documentation is current and available upon request.
- Ensure accurate results, adherence to Company protocols, and timely completion of projects.
- Interface with corporate partners regarding quality issues, audits, and special projects.
- Provide guidance to Manufacturing regarding quality and cGMP issues to ensure compliance with regulated standards.
- Prepare and/or review documentation required for regulatory submissions.
- Maintain metrics for the QC function and continuously improve the area in terms of quality, efficiency and effectiveness.
- Actively lead initiatives toward continuous development, training, mentoring and/or coaching of staff in the Quality Control organization.
- This position is responsible for other duties as assigned.
- Bachelor’s degree in a Technical or Engineering discipline required.
- Experience implementing Design for Compliance and training programs.
- Experience with Lab/ IVD/ Medical equipment is preferred.
- Excellent interpersonal and communication skills with ability to effective interface with technical personnel at various levels of the organization.
- Ten (or more) years of progressive professional experience, with a minimum of 5 years in management within pharmaceutical Quality Control.
- Strong knowledge of regulatory guidelines and their application.
- Excellent written and verbal communication skills.
- Ability to act quickly and decisively.