- Work closely with operations and the business functions to ensure quality performance of product and processes. (SGS).
- Work closely with customers, sales/marketing/field personnel, and cross-functional teams to address top quality issues. (DD).
- Oversight of NC/CAPA, activist and mentor in problem-solving and root-causing activities.
- Lead and participate in the development and improvement of the manufacturing processes for existing products. (SGS).
- Review of change management activities.
- Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, take action as necessary.
- Support execution and analysis of complaints and product field actions.
- Advocate of Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.
- Proficient understanding of risk management practices and concepts.
- Develop and provide input by identifying opportunities and weaknesses.
- Proficiency in understanding of optimization of inspection methods and sampling. (SGS).
- Proficient in statistical methods and application.
- Participate and interface in internal audits providing effective narrative and description of topic of expertise, participate in external audit preparation building confidence and proficiency in interactions.
- Assist in the development and review of process and equipment validation/qualification. Build proficiency in validation processes. (SGS).
- Support manufacturing transfers to other plants/facilities, leading quality activities. (SGS).
- Responsible for initiation, internal containment, and support of ship and product holds for potential product escapes.
- Coach and mentor others in quality topics and activities.
- BS in a science, engineering or related discipline.
- MS, CQE, or CRE preferred.
- Six Sigma Green or Black belt preferred.
- Minimum of 3 years experience preferred.
- Previous industry experience desired.
- Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.
- Understanding of US and International Medical Device Regulations.
- Familiarity with ISO 13485, GDP, GMP desired.
- Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
- Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
- Ability to represent Quality function with project teams.
- Strong interpersonal skills, written, oral communication and negotiations skills.
- Strong in critical thinking and "outside the box" thinking.
- Highly developed problem solving skills. Strong analytical skills.
- Demonstrated ability to successfully manage and complete projects in a matrix organization.
- Demonstrated ability to work independently and as part of cross-functional teams.
- Experience in working in a compliance risk situation.
- Computer literacy.
- Some travel may be required.
Report job
