Vacancy caducado!
- Function as quality expert for all product development activities by providing quality planning and guidance that ensures compliance with design controls, robust testing and assurance of quality; continual identify and implement improvement activities to enhance the quality system, processes, products and standards by applying expert use of quality tools and statistical analysis
- Define and implement processes for the early identification, correction and prevention of process and product quality non-conformances
- Develop and implement process controls for new products and for transfers to manufacturing
- Plan, develop and validate robust test methods which ensure acceptability of products under test
- Provide leadership and guidance in production process optimization through the planning of activities (process mapping, data gathering, process analysis, validation, and the documenting of results)
- Develop and implement statistical process controls and sampling plans
- Write, review and approve validation protocols for new products, processes and equipment, ensuring systems, utilities and processes comply with regulations standards
- Mentor team members as needed, particularly in the areas of data analysis and interpretation as they relate to quality assurance
- Conduct and document root cause investigations in a systematic manner; ensure identified causes and associated corrective actions will reduce or eliminate sources of non-conformance
- Participate in internal and external audits
- Implement the analysis of risk at all phases of product development and production to ensure the safety and efficacy of company products
- Maintain and advance and up-to-date knowledge of Quality Systems Regulations and other relevant quality principles, regulations and standards
- Bachelor's degree, or equivalent, plus a minimum of ten (10) years previous experience, preferably within a regulated medical device or pharmaceutical environment; post graduate degree, or equivalent, preferred
- Previous experience working on projects and issues that significantly impact the overall success of an organization a plus
- ASQ certification and/or Six Sigma Green/Black belt strongly preferred
- Experience with new product development (medical device or pharmaceutical) preferred
- Expert knowledge of quality engineering principles required
- Expert knowledge of Quality System Regulations required
- In-depth practical experience with process and product quality, statistical sampling and analysis, design of experiments (DOE) gage R&R, ANOVA and validation required
- Superior technical writing skills required
- Superior communication and presentation skills
- Knowledge of Microsoft Office required; knowledge of statistical software, and experience with large enterprise resource planning (ERP) system required
- Superior planning and organizational skills required
- Must be self-motivated and have the ability to work with minimal supervision; must also be able to work as part of a team
- A demonstrated excellence of problem-solving skills required