EDUCATION

• A minimum of a bachelor’s degree (Biological Sciences, Engineering, or a related field of study); an advanced degree is a plus.
• 10+ years of related experience in quality systems.
• Project Management certification (PMP, CSM, etc.) is a plus.

EXPERIENCE

• Strong expertise and practical experience with Project Management concepts and processes; including both Waterfall and Agile Methodologies.
• Experience working in regulated environments with applicable regulations/standards to GSG business including 21CFR820, 21CFR803, ISO 9001, ISO 13485, IVDR, cGMP’s, FDA Guidelines, USP, and GxP.
• Detailed knowledge of medical device manufacturing processes and experience with risk management regulations and standards, including FDA 21 CFR 820, MDSAP, IVDR, ISO 13485, and ISO 1497.
• Detailed knowledge of software validation best practices; especially those in a regulated environment.
• Proven ability in leading compliance projects, harness the benefits of working with cross-functional teams, and deliver on implementation strategies. Experience managing direct reports is a plus.
• Experience with PPI, Six Sigma, or Lean Methodologies is a plus.

KNOWLEDGE, SKILLS, ABILITIES

• Demonstrates strong critical thinking and analytical skills; self-motivated, proactive, and able to complete projects on time.
• Strong verbal and written communication skills; able to effectively communicate at multiple levels in the organization.
• Passionate about achieving goals and experienced in building, inspiring, and guiding successful teams.
• Ability to travel.

Please refer the Job description for details