Johnson & Johnson Careers
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Senior Quality Engineer
Requisition ID: 6607171208
Johnson & Johnson’s Cardiovascular & Specialty Solutions (CSS) Group within Medical Devices is recruiting for a Senior Quality Engineer for Sterilmed located in Plymouth, MN with up to 10% travel.
The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Surgical and Non-Surgical Aesthetics, Neurovascular, and Reprocessing. The CSS Group is committed to delivering innovative products, solutions and programs to address unmet customer and patient needs around the world. Our customers and the patients they treat are our first priority and these values are reflected in Our Credo, which guides our daily decisions and actions. Our relentless commitment to Quality and the principles that define us in Our Credo have helped us achieve significant milestones and continues to help us deliver significant growth year after year.
The Senior Quality Engineer performs quality support duties including maintenance of the issue escalation and field action processes. Provides support for special quality projects. Lead failure investigation process to determine root cause of failure.
• Collaborate with representatives from other functional areas to facilitate Risk Analysis, Design Control Processes, and approve Design Validation & Verification documentation.
• Support Internal Audits and will be accountable for preparing and tracking Audit Finding Reports (AFRs) in response to observations from internal and external (3rd party) inspections / audits to ensure compliance with Quality Management System elements.
• Serves as a Failure Risk Management, Design Control or Validation & Verification.
• Supports New Product Introduction and Design Changes.
• Works on complex investigations and coordinates technical teams to ensure sound experimental design, effective data analysis, identification, risk analysis, design control and verification and validation and subsequent closure to technical investigations.
• Provides back room support for 3rd Party Inspections and Audits (e.g. Registrar, Notified Body, FDA, or customer audits).
• Provides training regarding Quality Management System Elements to representatives from other functional areas.
• Identifies opportunities to continuously improve quality systems and processes in alignment with overall quality and business objectives.
• Supports and participates in cross-functional projects when assigned/appropriate.
• Facilitates technical innovations to enhance Quality Systems and support business goals.
• Assists with other Quality System activities as requested by management.
• Performs other duties assigned as needed
• A Bachelor’s degree, preferable in a Science, Technical or Engineering related field with a minimum of 4 years of professional work experience within Quality Assurance, Quality Engineering or Quality compliance is required.
• Experience in risk assessment/mitigation is required.
• Experience in new product development and process validation is required.
• Experience working in a Quality and Compliance environment in the medical device industry (GMP) or similar is strongly preferred.
• Strong analytical skills with deep knowledge of how to achieve process improvements and the conversion of data into meaningful business information is required.
• Excellent communication and relationship management skills in order to quickly build credibility within the Quality and Compliance community, partner with executive management and external regulators is required.
Sterilmed, Inc. (6215)