* Key Responsibilities:

• Provide sound, risk-based QA direction and independent and timely decision-making on a wide range of quality and compliance issues. Includes working with suppliers and internal resources to perform root cause analysis/failure investigations, identifying and approving of supplier corrective actions, and monitoring supplier’s implementation / effectiveness. Provides oversight and escalation for product related issues. • Ensure compliant execution of Quality Management Systems including but not limited to EM: selection, change control, qualification, approved supplier list, NC/CAPA, Quality agreements and performance monitoring. • Provide leadership across activities associated with supplier risk identification & management, including planning and execution of supplier risk & control plan assessments and the ownership and creation of Quality Agreements .• Exercise strong communication and interpersonal skills, with the ability to work independently and in a team environment, to effectively support supplier relationship • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements under limited supervision • Adaptable and flexible for other duties that may be assigned as needed

Senior Supplier Quality Engineer a minimum of four (4) years of relevant work experience. • Hands on production line experience with validations • NC/CAPA root cause analysis, FMEAs, NPI, Design Control, Supplier Quality, medical device • Someone already experienced with J&J would be preferred for quick onboarding and less learning curve. • Critical thinking skills, excellent written and verbal communication skills with attention to detail. • Demonstrated project leadership experience within regulated quality environment

• The candidate needs to have supervisory skills as he/she will be responsible for meeting the project timelines required for team. • Creation of charts, scheduling etc. using Excel • Program Management skillset