Quality Engineer

Role Summary

Quality Engineer responsible for supporting Quality Engineering requirements for new product development, legacy product maintenance activities, continuous improvement, risk management and customer satisfaction. Serves as a subject matter expert and liaison between the company and customers/vendors to resolve quality and manufacturing issues and ensure positive communication to maintain customer satisfaction.

Responsibilities

• Key member of complaint and MRB investigation teams. Analyze, identify, develop and implement manufacturing, production, and other process improvements which will improve capability and/or performance. Meet with appropriate teams and/or individuals to offer recommendations and share results.
• Create Failure Mode and Effects Analysis (FMEA) for new and existing products based on risk assessment and in alignment with ISO 14971:2019. Collaborate with R&D and Regulatory department personnel to align risks identified and mitigations to reduce and control risk.
• Quality representative for new equipment program. Evaluate new equipment for validation requirements. Act as a reviewer/approver on equipment validations performed by other departments.
• Represent the company via interactions with suppliers including new products, Supplier Corrective Action Reports, change notifications, etc. Review SCARs sent back from suppliers to assess corrective actions. Conduct and/or participate in supplier audits.
• Represent Quality on new product development teams and transition new designs into production. Work closely with Operations personnel to develop strategy and plans for implementation.
• Schedule and lead periodic cross-functional meetings to review the Validation Program. Recommend process/equipment candidates for re-validation based on changes to operations, processes and practices. Write, review, and approve validations, when necessary, (IQ/OQ/PQ protocols, SOPs, technical reports, and final reports) for new products, processes, and equipment; ensure systems, utilities, and processes comply with FDA and industry standards.
• Participate in management review meetings and/or prepare information and trending data to be shared in the meeting.
• Enable positive communication channels internally and externally to ensure the highest level of customer satisfaction.
• Develop, prepare, and implement Quality Program plans for new and existing customers specific to validation and qualification activities.
• Author new or revised SOPs per the QMS while ensuring consistency of processes and verbiage; act as a signatory in Change Control when necessary.
• Actively participate in internal, customer, and third-party audits.
• Other duties as assigned.

Qualifications

• Minimum Job Requirements: Bachelor of Science degree in Quality or Mechanical Engineering or similar.
• Minimum 5 years‚Äô experience as a Quality Engineer in a manufacturing environment.
• Diagnostics, pharmaceutical or biological products manufacturing experience is preferred.
• Proficient in understanding and application of ISO13485. Auditing, Six Sigma and Lean Manufacturing experience a plus.

Skills

• Manage time effectively and prioritize multiple competing tasks.
• Ability to identify and solve problems, develop innovative solutions, act decisively, and apply good judgment.
• Diplomatic handling of situations; willingness to offer opinions and take action when necessary.
• Strong communication, interpersonal, problem-solving, organizational skills; self-directed and able to relate to all levels of the organization.
• Strong computer skills (Word, Excel, PowerPoint); experience with Access is a plus.

Education

• Bachelor of Science degree in Quality or Mechanical Engineering or similar.