Senior Supplier Quality Engineer – Indirect Materials

Role Overview

• Provide leadership in design i& implementation of world-class quality engineering to support entire product life cycle with focus on quality engineering activities such as reliability, root cause/corrective action risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of the products.
• Activities include driving correction, corrective action, prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction.
• Provide leadership and technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems.
• Provide review and approvals for the release of new products ensuring quality requirements are met.
• Provide leadership & support to J&J process excellence initiatives including Six-Sigma, design excellence & lean thinking.
• Direct development & consistent application of quality policies & procedures in product design & development, secondary development, manufacturing, external manufacturers & suppliers.
• Responsible for following and administering safety.
• Compliance with safety policies and procedures.
• Follow J&J and EES Records Management Policies for Convenience Information, Records Retention Schedules, Training and Education, Document Hold Notices, Records Cleanout, Inactive Records and Information Management, Vital Records and third party vendor if applicable.
• Other responsibilities may be assigned and not all responsibilities listed may be assigned.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

Requirements

• 3-4 years of related work experience
• Experience in a regulated industry (Medical, automotive, aerospace, etc.)
• Regulatory compliance knowledge: GMP, MDD (Medical Devices Directive), 510K (Pre-market approval), and Government, trade association, industry & medical publications
• Communication (written and verbal)
• Negotiation / influencing
• Quality Assertiveness
• Analytical & Creative thinking
• Project Management skills to support multiple projects simultaneously
• Problem-solving & priority setting
• Organizational & integral-synthesize information from a variety of sources
• Understand concepts quickly
• Research and maintain ongoing learning of industry and regulations
• Experience with Microsoft Office (Windows)

Benefits

• Vacation –120 hours per calendar year
• Sick time
• 40 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time
• up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year