Quality Engineer Sr

Job description

JOB DESCRIPTION:

Position Summary:

This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering leadership and support for commercialized products, manufacturing, and/or system/services support. Will have responsibility for quality compliance for products produced in the Costa Rica facility. Works with minimum supervision and has appreciable latitude for interviewed actions. Assignments are broad in nature and employee uses discretion to design project task and to bring the project to completion.

Essential Functions:

• Provides Quality Engineering Body of Knowledge leadership and support to company and organization.
• Develops and maintains master documents, protocols and reports for quality planning, process validation, risk management and qualification of test methods and inspection methods, among others.
• Implements and conducts data analysis, systems evaluation, and product assessment to ensure finished products meet standards and specifications; implement and drive changes where needed.
• Lead the investigation, resolution and prevention of product and process nonconformances.
• Ensures compliance to ISO 13485 & 21CFR 820 Quality System Regulations.
• Utilizes Six Sigma and other quality tools to implement process improvements to enhance product quality and reduce process variance by identifying improvement opportunities in regulation compliance, device, process, and system quality, and cost reductions.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Appropriately document and execute experiment and validation plans and results, including protocol writing and reports for process optimization and/or improvement
• Provides expertise in engineering evaluation and experimentation to determine if product and process capability requirements are being met, and continually improved, within the routine manufacturing process.
• Lead in the completion and maintenance of risk analysis
• Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
• Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities.
• Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
• Lead, coach, and mentor non-exempt and entry level exempt personnel.
• Performs other duties as assigned.

Qualifications:

• Bachelor's degree required in Engineering, Technical Field, or bachelor's degree in business administration with at least 7 years experience in Quality Engineering positions.
• At least 5+ years of experience, with preferably 3+ years in quality engineering roles.
• At least 1-year of experience in supervision role preferred.
• Experience with process validation and method qualification.
• Experience on use of Quality tools/methodologies
• Detailed knowledge of FDA, GMP, and ISO 13485.
• Experience in process improvement tools such as: (Root Cause Analysis, Fishbone, Is/Is Not, etc.), Six Sigma or Process Control & Monitoring (SPC).
• Project management experience, participating or leading multi-departmental project teams.
• Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
• Advanced command of English

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