SR QLTY & RELIABILITY ENGINEER

Job Overview

SR Quality & Reliability Engineer  leads continuous improvement initiatives for the QMS. They work on systemic evaluation of quality processes, products, services, facilities, and manufacturing processes, to ensure that standards of quality are being met. Develop and implement quality plans, CAPAs, programs and procedures using current FDA regulations, ISO 13485 standard and other site  standards in conjunction with other tools such as quality control statistics, lean manufacturing concepts, and six-sigma tools and analyses. They review, analyze and report on quality discrepancies, investigates problems and executes quality audits. SR Quality & Reliability Engineering II works closely with manufacturing, engineering, customers, or suppliers and subcontractors to ensure requirements are met.

Responsibilities:

• Works closely with strong collaborative team working environment with focus on compliance, customer needs, and product quality.
• Identifies process and procedural gaps and ensures policies/procedures are implemented to fulfil the organizational business strategy.
• Tracks and reports quality metrics such as KPIs.
• Ensures relevant  policies and procedures are implemented, maintained and adhered to.
• Recommends modifications to existing quality or production standards to achieve optimum quality; works with product developers to resolve non-compliance issues.
• Promotes awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
• Drives continuous improvement initiatives to enhance the site quality system and product quality ensuring compliance to governing regulations and corporate policies and procedures.
• Familiar with establishing inspection standards, plans, frequencies and test methods, and the practical application of quality engineering tools (Six Sigma).
•  Leads and demonstrates expertise in the areas of QSR and ISO standards within one’s own group, constantly promoting awareness of best industry practices and making appropriate decisions on a daily basis.
• Familiarity with Risk Management and making risk-based decisions throughout the product development life cycle.
• Ability to make quality decisions, and resolve complex and development issues, while mitigating risk to end user or patient on a daily basis, and escalating when appropriate to the site leadership team. 
• Provides best in class root cause analysis & problem-solving guidance.
• Leads CAPA implementation efforts for continuous improvement of systems 
• Works cross-functionally to deliver on the site strategic targets and objectives.
• Participate in Site & Corporate initiatives.
• Support the site during regulatory and customer audits
• Performs assigned internal audits to ISO 13485 & CFR Part 820 
• Liaison between the cross functional departments and Quality leadership.
• Fosters an environment of team collaboration
• Supports and leads projects in the Quality department for improvement and compliance initiatives 
• Reporting directly to the Campus Quality Manager. 
   

What your background should look like:

• Bachelor’s Degree in science, Engineering or related subject desirable. 
• 5+ years relevant quality operations experience in GMP manufacturing environment in Medical Device/Pharma industry.
• Six Sigma Green/Black belt desirable
• Lead Auditor ISO 13485 certification a plus
• Excellent coaching/mentoring skills.
• Excellent communication skills and have demonstrated the ability to lead in a previous role.
• Excellent communication skills. Must be proficient in English, verbal and written
• Strong team building skills with abilities in decision making and sound personal judgment
• Good organization and investigation skills are required.
• Ability to influence
• Excellent “hands-on” technical skills.
   

Competencies