Drive continuous improvement in supplier performance through utilization tools such as Six Sigma DMAIC, FMEA, SPC, 8D Root Cause Analysis and Lean Manufacturing concepts.
Optimize process capability on significant characteristics through effective application of statistical analysis techniques and training of Suppliers in problem-solving.
Utilize analytical skill sets to implement root-cause analysis and provide recommendations for corrective action.
Support the efforts to plan, implement and maintain a plan of action to revise the existing Quality System labelling and QC documentation in accordance with compliance requirements and the strategic needs of the business.
Facilitate the incorporation of quality systems/regulatory requirements in accordance with FDA QSR (21 CFR Part 820), ISO13485: 2016, European MDD / MDR, and all other applicable regulations.
Facilitate the incorporation of a process risk management procedure that defines the incorporation of a risk-based strategy for process changes, development, validation, and continuous improvement.
Support the resolution and closure of corrective actions and continuous improvement efforts for quality management systems.
Emphasize the awareness of quality system requirements, processes, and deliverables throughout the organization.
Provide active support for internal, third party and customer audits.
Provide practical, useful, and effective quality systems reports for senior management, management reviews, business strategic initiatives and specific requests.
Complete other responsibilities as assigned.
Knowledge, Skills and Abilities
Knowledge of medical product manufacturing and development: 21 CFR 820 (Quality System Regulation), 21 CFR 803 and 804 (MDR regulations), ISO 13485, ISO 14971, and MDD 93/42/EE.
Solid understanding of receiving inspection processes including statistical sampling, component measurement techniques, specifications, and drawings.
Thorough working knowledge of Quality systems methods and practices (DOE, PFMEA, Control Plans, Lean Manufacturing concepts, DMAIC, Root Cause Analysis, etc.).
Understanding of CAPA and closed loop corrective action.
Proficiency in Microsoft Office applications as well as other Document Control software applications.
Ability to interact effectively (both verbal and written) with associates across all departments within an organization at all levels.
Must have strong proofreading skills and organizational skills, as well as exemplary attention to detail.
Must have demonstrated initiative and ability to work independently while handling multiple tasks.
Strong written, verbal, and interpersonal communication skills.
4-year degree in engineering, scientific discipline, or similar required; or equivalent combination of education, training, and experience.
Minimum of 2 years of experience of involvement and/or management of manufacturing of Class II or III medical devices required.
Experience in working with suppliers including contract manufacture(s) on medical product quality issues, including supplier evaluation and on-site auditing required.
Experience in writing SOPs, change orders, labeling and/or other documents required.
Experience in document control and labeling operations preferred.