Day-to-day Risk Management review is anticipated. Strong Risk Management experience is a must.
Develop, execute, analyze, and report on validations/qualifications activities including but not least: IQ, OQ, PQ, MVP, Test Method Validations to support commercial release product lines.
Evaluate, review and/or update Risk Management files to follow ISO standards and local procedures.
Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
Works directly with operating entities, with multiple functions, internal and external, to provide quality engineering support to assure requirements meet project expectation and meet local procedures and regulations.
Prepares reports and/or necessary documentation in the project scope, and provides to applicable stakeholders, both internal and external on scheduled expected time.
Develops, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
Implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment when required.
Specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis of products or materials to meet required standards and specifications.
Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
Perform detailed Root Cause Investigation of failed product or processes using various quality tools (5 Whys, 6 M, Ishikawa Diagram, Pareto Charts) when required.
Interface with Production, Manufacturing/Process Engineering, R&D, and Regulatory departments to resolve process issues and implement changes.
Apply knowledge of process control tools, statistical sampling, and other analytical techniques on the qualification activities to maximize the quality and flow of product through the production line.
Identify, analyze, and manage risk through product life cycle with use of risk management tools.
Qualifications
Quality with Strong Experience in Validation/Qualification activities: (Write, coordinate, execute, create reports, IQ, OQ, PQ, MVPR, Sampling size determination: For Attribute or variable data, Strong statistical background, etc)
Required Skills
Strong Risk Management Experience (Experience in Risk Documentation: Write, review, approve of Risk Management files, RPM calculations, Risk Mitigations, etc.)
Able to work with minimum of supervision in a hybrid working organization set up.
Good writing and documentation skills.
Good organizational and verbal communication skills.
Ability to work in fast-track schedule and meet deliveries on time.
Ability to communicate effectively.
Ability to interact with a very diverse team keeping high ethics standards.
Preferred Skills
ASQ Quality Engineer Certification.
Bilingual English/Spanish preferred but not required.
Previous Medtronic and/or Medical Device experience is helpful.
DMAIC Lean / Six Sigma Certification.
Manufacturing experience within a controlled and regulated industry.