Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Quality Engineer for a 6 month + Contract. Our client offers results-driven people a place where they can make a difference every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
Position Description (Principle Duties and Responsibilities)
Ownership for internal quality performance and measurement including KPI s and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews
Lead quality issues and partner with Internal Customers; Lead effective supplier containment and corrections/corrective actions
Act as point of contact for Internal/ External Customer groups on key compliance issues related to assigned projects
Participate in Internal Audits as needed. Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.E. FDA, IMB, Notified bodies, etc)
Responsible for accuracy and integrity of inspection data that ensures compliance with documented procedures & processes
Ownership and reporting on all quality issues associated with assigned products/ projects. Ensure all assigned related material quality issues are effectively communicated to key stakeholders
Participate in material related processes which include: Material Review Board to ensure Coordination of MRB activities with the business unit to ensure the timely assessment of potential non-conforming products.
Support ongoing initiated change requests submitted by internal teams.
Support/lead investigations related to nonconformances & CAPAs for internal related defects
Partnership with operation to support cost efficiency initiatives.
Partner with internal teams on internal drawing changes that lead to print updates/process changes internally and at suppliers (CMs)
Update inspection plans, oversee execution of gage R&R studies, etc. As deemed necessary from CMs.
Maintain structured communication channels with strategic sourcing, identifying responsibility by commodity / supplier.
Liaising with the Manufacturing and Quality groups, in assessing and addressing material quality issues with assigned projects.
Deliver continuous improvement activities focusing on quality
Participate as required in CRB in conjunction with key stakeholders
Support assessment of material/ processes changes
Participate in internal audit program planning, execution and closure
Participate in cross functional projects both locally & globally as required
Develop sampling plans by applying attribute, variable, and sequential sampling methods.
Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.
Bachelor s Degree in Engineering or Science fields
Minimum of 2 years experience in manufacturing environment or equivalent.
Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
Good knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment
Demonstrated working knowledge to positively influence quality performance
Analytical and problem solving capabilities with the ability to draw insights from data quickly and to define executable actions
Ability to plan, organize and implement multiple concurrent tasks
Strong communication/ influencing skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.
Demonstrated ability to work in cross-functional team environments
Willing to travel in support of business needs to different geographical locations. (up to 20%)
Good knowledge of continuous improvement methodologies
Professional Requirements- Desirable:
Preferred industries are medical device, aviation, aerospace, automotive and defense
Internal Quality Auditor Qualification either in AS 9100 or ISO13485, CFR820 or comparable industry standards and regulatory requirements