Quality Engineer

For Quality Engieneering services in the CTW and Sustaining Projects area.

About fitspr

• Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members.
• In other words, being a customer service pro is one your (many) talents.
• Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table.

Are you ready to take on this new challenge?

• AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Serve as the Quality Engineering representative and core team member for assigned CTW and sustaining projects.
• We are a Service Provider company different from the rest.
• We pride ourselves in how we treat the most important piece of our company's puzzle: you!
• We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!).
• Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent.
• We're FITS!
• Are you the next piece?

Responsibilities

• FDA Quality System requirements, 21 CFR Part 820, ISO 13485, and GMP requirements.
• Reviewing and approving technical protocols, reports, specifications, risk assessments, FMEAs, validation documentation, and engineering change records.
• Provide Quality Engineering leadership throughout project initiation, execution, implementation, and closure.
• Develop and execute risk-based quality strategies based on project scope, product impact, regulatory requirements, and technical risk.
• Assess proposed changes to products, materials, suppliers, manufacturing processes, equipment, specifications, packaging, labeling, and related systems.
• Quality impact assessments and ensure change-control activities adequately address product quality, patient/user safety, compliance, and validated state.
• Support Design Control activities, including assessment of design inputs, outputs, specifications, acceptance criteria, and design changes.
• Review and approve applicable design reviews, verification and validation documentation, risk-management deliverables, and change-control records.
• Determine appropriate verification, validation, qualification, and test requirements based on the nature and risk of proposed changes.
• Review protocols, reports, engineering studies, test method validations, sampling plans, statistical analyses, and process/equipment qualification documentation.
• Lead or support product and process risk-management activities, including FMEAs, risk assessments, risk controls, and Risk Management Files.
• Evaluate manufacturing process changes and associated data to assess process stability, capability, performance, and impact to product quality.
• Support investigations involving nonconformances, deviations, Quality Notifications, unexpected test results, and product/process failure modes.
• Apply statistical techniques such as process capability, SPC, hypothesis testing, confidence intervals, regression, ANOVA, measurement-system analysis, and acceptance sampling.
• Ensure projects comply with applicable Quality System requirements, including FDA requirements, 21 CFR Part 820, ISO 13485, GMP, Design Controls, Process Validation, and Test Method Validation.
• Author, review, and approve technical and Quality documentation while ensuring decisions and rationales are scientifically justified, evidence-based, and compliant with Good Documentation Practices.

Requirements

• The Technical Part: Bachelor’s degree in Engineering, Science, or a related technical discipline, with 3–5+ years of relevant Quality Engineering experience in the medical device, pharmaceutical, or other highly regulated manufacturing industry.
• Bilingual, Spanish and English (good communication) Shift: Administrative & according to business needs Experience in: Sustaining engineering, CTW, change-control, or product lifecycle projects.
• Design Controls, risk management, change control, verification and validation, process validation, and Test Method Validation (TMV)..