- Responsible for drafting and/or updating Quality Procedures for Quality Operations functions.
- Responsible for Non-Conforming Material Reports (NCMR) including root cause investigation, risk assessment, historical record review, disposition strategy, correction activities.
- Responsible for Complaints Reviews/Manufacturing Analysis including event assessment, root cause investigation, risk assessment, historical record review, impact/action escalation.
- Responsible for Corrective Action Preventive (CAPA); including root cause investigation, scoping/bracketing, resolution planning, implementation, and verification of effectiveness.
- Support/participate in regulatory agency and customer quality audits.
- Working knowledge of concepts of probability and statistics as well as aide in updating/establishing SPC and Gage R&R studies.
- Work with suppliers of both raw materials and components to improve product quality and/or resolve quality issues.
- Write and or assist in development of protocols, technical investigation plans, engineering reports, and related procedures which ensure statistical validity, adequacy, and compliance to regulatory and corporate requirements.
- Act as a Quality lead to oversee day-to-day Manufacturing activities
- Responsible for driving continual process improvements in responsible areas of the business. Drive quality and manufacturing improvements to assure that processes are in a state of control.
- Responsible for Manufacturing/Production Line Support - partnering with operations team members to achieve value stream goals and objectives.
- Provide input and expertise to manufacturing on sample sizes and statistical methods.
Design Assurance Responsibilities
- Review and approve changes made to product and processes and validation/qualification protocols and reports
- Initiate and develop standards and methods for inspection, testing, and evaluation as necessary. Assure product compliance to specifications through implementation of inspection criteria, procedures, and training.
- Draft, review, and maintain pFMEAs. Work with customers to draft and review dFMEAs.
- Participate in design control activities to ensure that product meet specifications, reliability, and manufacturability.
Design Assurance Responsibilities (cont.)
- Develop and execute to Validation Master Plans, Equipment Qualifications, Process Validations, and test method validations for successful transfer from development to manufacturing working in a cross-functional group.
- Develop requirements for specifying critical product requirements after collaboration with design engineering, manufacturing engineering, Customers and Suppliers.
- Promote quality through process discipline and first-time conformance throughout the product development and manufacturing processes.
- Develop and maintains effective relationships and integrate activities with other departments and suppliers (as needed).
- Mentor manufacturing and engineering staff on root cause techniques, problem solving, and formulation of impact assessments and justifications.
- Identify and lead projects and initiatives to improve the quality system.
- Coach and develop other team members.
- Recommend and make changes to QMS procedures, SOPs, Work Instructions, and other related documents, as necessary.
- Knowledge of quality/continuous improvement tools (SPC, Statistics, DOE, Six Sigma) preferred
- Good oral and written communication skills.
- Ability to write reports, data analysis, and business correspondence.
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
- Ability to clearly and concisely convey project accomplishments, obstacles, issues, and status to project team members.
- Ability to work with mathematical concepts such as probability and statistical inference.
- Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Experience, Knowledge and Skills
- Statistical and data analysis skills.
- 5+ years of work experience in the medical device industry.
- Experience with ISO 13485, and FDA 21 CFR part 820.
- Proficient computer skills (MS Office, Excel).
- Excellent verbal and written communication skills. Must be detail-oriented and able to work independently.