JOB SUMMARY
Supervises the Quality Validation team to allocate detailed validation work on a specific portion of a broader task assigned to experienced engineers. Duties are assigned to provide experience and familiarization with validation methods, independent thinking, and company practices and policies.
ESSENTIAL DUTIES
- Manages and provides guidance for the Quality Validation group development, effectiveness, adhering to organizational policies and processes and supporting overall business and corporate targets
- Serves as expert and main point of contact for Validation issues within area of responsibility.
- Reviews and approves relevant validation documentation as per assignment and within area of responsibility.
- Influences the organization in quality objectives, prioritization and resourcing decisions as necessary.
- Acts as an internal key contributor for validation initiatives aimed at improving product quality, business systems and compliance; may be the primary representative of validation group on projects.
- Understands FDA (CFR 820, 211, 210 and 21 CFR 11), ISO (13845 and 14971) and other regulatory requirements and validation guidance such as GHTF 2004 and FDA Process Validation Guidance 2011, ISPE GAMP5, PDA, ICH etc...
- Ensures compliance with Quality System and safe working practices.
- Plans, guides, and reviews projects and or work groups under one's control to produce the desired outcome.
- Utilizes technical skills to evaluate proposed solutions, adaptations, and modifications to projects.
MINIMUM QUALIFICATION REQUIREMENTS
Education
- Bachelor's degree in Science or Engineering is required
- Master's degree in relevant field is preferred.
Experience
Minimum 7 years working experience with at least 5 under a regulated environment.
Skills
- In-depth knowledge of U.S. and international medical device and drugs regulations and standards (21 CFR 820 & 210, 211, 11, EU MDR and ISO 13485).
- Strong interactive skills in cross functional participation and influence, mentoring and acceptance of guidance, project management, coordination with cross functional team members, and support for subordinates, junior engineers, technicians, and management.
- Strong analytical and logical thinking skills and key part-taking in problem-solving in collaboration with relevant functions
- Interacts with senior level external associates on significant technical matters often requiring coordination between organizations.
- Follows technical specification requirements and provides significant input on validation procedures
- Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
- Regularly and effectively presents complex technical information/analysis, and responds to questions from technical staff members and management.
- Demonstrated ability to communicate effectively both verbally and in writing. Good command of English language required to attend meetings with English speaking associates and to write technical documentation.
- Knowledge and use of relevant PC software applications and skills to use them effectively.
PHYSICAL REQUIREMENTS
General Labor Environment requirements include use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 25 kgs
The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
Additional Physical Requirements
Requires travel based on business needs.
