Ultimate Solutions Corp. is a trusted provider of packaging industrial automation, serialization and compliance for the Life Science Industries in Puerto Rico, United States and Europe. Over a decade, the Ultimate team has deliver proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices and logistics markets.
Advanced Quality Engineer
Responsible for quality system support for R&D projects; provide inputs to R&D designs from a quality perspective; work closely with R&D to develop verification and validation strategies for product designs and analyze the risk associated with these designs; provide statistical support and analysis; improve quality processes as they apply to new/existing product design. Works with minimum supervision for performing their duties.
Essential Duties & Responsibilities
- Prepare and conduct design reviews by identifying risks associated with the product in scope and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the product development process.
- Help guide R&D through our internal quality system to ensure products are developed in compliance to those procedures as well as the requirements of the FDA, ISO, and other regulatory bodies.
- Review and evaluate project documentation for compliance as well as sound technical competence to ensure we are delivering robust products/processes.
- Establish safety, durability, craftsmanship, and reliability design input specifications based on predicate device quality reports, design reviews, risk analyses, customer research and VOC activities.
- Support the definition of design verification and validation test requirements that ensure appropriate statistical rationale and objective evidence is available to support the acceptance criteria.
- Provide input throughout the new product development process from a quality perspective.
- Perform risk analysis and develop mitigation strategies, and partner with R&D to identify design output solutions that satisfy the product requirements.
- Collaborate with Design engineers to develop robust verification test strategies to ensure safe, reliable products are implemented.
- Supports R&D on the use of risk management tools, statistical methods, design and process control activities, and sound verification and validation test planning to help drive quality upfront in new product development.
- Perform component qualification activities surrounding PPAP
- Develop, create and update, as appropriate, procedures for incoming, in-process, and final inspections for new/existing product development
- Develop and establish usability scripts and protocols for formative and summative evaluation, as well as new product development plans and documentation relative to design validation.
- Analyze and define critical quality attributes for product and process through risk analysis
- Support Advanced Operations in the development of manufacturing processes for new products.
Education & Special Trainings
- B.S. Degree in science or engineering required.
- M.S. om Science or engineering preferred.
- Six Sigma Green or Black belt preferred.
Qualifications & Experience
- 3+ years relevant experience required.
- Understanding of FDA, ISO 13485, and ISO 14971 and other regulations and standards preferred.
- Competent with Microsoft Office (Outlook, Excel, Word, etc.)
- Must possess excellent oral and written communication skills in English and Spanish
- Ability to solve problems in a high stress situation
- Eagerness to assist internal and external customers
- Manage projects in a timely manner
- Ability to conduct and document technical investigation
- Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
- Demonstrated ability to effectively work globally and cross-functionally with other departments, including Advanced Operations, Product Development, Regulatory Affairs, and Marketing.
- Strong in critical thinking and "outside the box" thinking.
- Demonstrated ability to advocate for product excellence and quality.
- Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) preferred.
- Must be able to manage time, projects, stress and conflict.
- Must possess strong interpersonal skills including written and oral communication.
- Must be able to bring tasks through to completion with minimal supervision.
- Must have the ability to prioritize work and keep detailed and confidential records.
Ultimate Solutions Corp is an Equal Opportunity Employer