Reporting into the Quality Department, this role has responsibility for Quality related actions in support of New Product Development and Product Sustainment (both Design Quality and Supplier Quality Engineering) for Sports Medicine products as well as continuous improvement business projects.
Works collaboratively with project team members to develop and manage project plans. Champions design control and risk management activities for assigned projects.
Evaluates risk and verification implications for proposed post-launch design changes. Leads the implementation of data driven decisions and proven processes by utilizing tools and techniques such as six sigma / DMAIC, statistics, predictive indicators, process validation, SPC, DOE, PFMEA, PPM defective, root cause analysis, etc.
Deploys all critical to Quality (CTQ) control plans and measurement system analysis.
Responsibilities : (Please specify % amount against each responsibility)
Develops and works with area teams to implement continuous quality improvement programs which may include efficiency improvements, cost savings programs, compliance improvement programs, and other initiatives as assigned) 40%
and support of process / product validation. Develops and implements inspection and testing techniques (Gage R&R), and Statistical Process Control (SPC) program. 15%)
Develops and administers an inspection, test, and / or audit program to ensure that incoming, in-process, and finished products meet functional specifications and quality standards.
Ensures completeness, accuracy, and testability of product requirements (Control plans, MSA, datasheets, inspection instructions, etc.) 15%)
Supports manufacturing operations and provide expertise in product requirements, risk management, test methods, and statistical analysis.
Works with outside labs and suppliers to communicate Smith & Nephew product / process requirements as well as assess capabilities of the outside lab / supplier. 15%)
Ensures compliance to product specific standards, cGMP, QSR, US FDA, ISO, IEC, UL, EN, and MDD requirements. Ensure that all the responsibilities within the scope of this job comply with the scope of the Quality System. 15%)
Education : BS in Engineering or technically related field
Licenses / Certifications : CQE, ISO 13485 Lead Auditor, and Six Sigma certification preferred
Experience : 6-15 years Quality Engineering experience in Medical Device Industry.
Hands-on experience in Medical Device manufacturing with working knowledge of FDA QSR, MDD, MDR, ISO 14971, and ISO 13485.
Competencies : Design Controls, MSA, DMAIC, Statistics, SPC, SQC, DOE, Process Validations Project Management Skills, Decision Making, Exercising Influence, Ability to Influence at all Levels of Internal / External Organization
Physical Demands : Light (0kg - 5kg)
Travel Requirements : 10 30%