Staff Supplier Quality Engineer

Role Overview

• Provides overall quality assurance leadership in the management of select contract manufacturing sites and raw material suppliers engaged in the production of Johnson and Johnson products.
• Maintains the qualification of suppliers and their processes as well as lead activities associated with resolving complex technical issues that may require the development of new or improved techniques or procedures.
• Support Quality Systems including change control, supplier non-conformances, ASL management, Quality Agreements and department procedures and system, as assigned.
• Perform and Support supplier/ EM quality evaluations and/or audits, development of quality agreements, and other quality related activities impacting supplier.
• Lead activities associated with resolving supplier quality issues working with suppliers and internal partners to perform root cause analysis/failure investigations, identifying and implementing corrective actions, and monitoring for effectiveness.
• Lead activities associated with supplier risk management working with suppliers to identify areas of high risk within their processes; establishing, monitoring and implementing supplier risk mitigation plans; participating in supplier risk management projects; ensuring management awareness of risks and tracking progress.
• Provide Quality Engineering support to suppliers including assessments, inspection technique support, verification/validation activities, CAPA and change management.
• Develop and report on supplier performance metrics.
• Participate in local site supplier quality meetings to ensure communication and alignment of quality initiatives.
• Responsible for communicating business related issues or opportunities to next management level.

Requirements

• Bachelor's Degree is required; Master’s Degree is preferred
• Generally requires 4 – 6 years of work experience in a GMP and/or ISO regulated industry
• Experience in the medical device / pharmaceutical industry is preferred
• Engineering or science field of study is preferred
• Excellent communication, teamwork, and problem-solving skills are required
• Expertise in all aspects of quality event investigations such as root cause analysis followed by comprehensive corrective action suggestions
• Experience with machining, injection molding, metal processing such as passivation, anodizing and heat treating, and/or electronics assembly are preferred
• FDA CFR and ISO regulations knowledge is required, with FDA CFR Part 820 and ISO 13485 knowledge preferred.
• Auditing background is a plus
• Six Sigma, Lean, American Society for Quality (ASQ) certification and professional licenses are preferred
• Strong statistical analysis skills are preferred
• Fluency in English is required

Tech Stack

• Assembly

Benefits

• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Vacation –120 hours per calendar year
• Sick time
• 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 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