For Quality Engineering services in the Quality area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering and at least (5+) years of experience performing quality engineering functions within a manufacturing environment . Bilingual: (Spanish and English). Soft Skills: Problem-solving, excellent time management, and good decision-making.
Shift: Administrative and according to business needs. Experience in: Fully bilingual (English/Spanish).
Verbal and Written Communication Skills Review of all validation lifecycle documentation, procedures, change control, risk assessment, among other documents."
Capable of managing multiple tasks and prioritizing own workload Intermediate skill in the use of Excel, Word, and PowerPoint; advanced preferred.
The Personality Part: 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 Be The Piece?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Provide support to Regulatory Affairs team in compiling, organizing, and managing EU MDR certification-related information pertinent to manufacturing sites operations.
Collaborate closely with cross-functional teams to aid in the identification and resolution of deficiencies related to regulatory compliance, ensuring timely and effective resolution.
Conducting investigation to identify the root causes, developing, and implementing actions to address process related issues.
Stay up to date on changes, conducting risk assessment / gap assessments to identify potential process related risks / gaps.
Collaborate with multifunctional teams to identify and implement process improvements!
Developing and implement SOPs to ensure consistent and reliable manufacturing operations processes.
Ensuring that processes are efficient, effective, and compliant with regulatory requirements and standards.
Providing training and guidance to employees regarding regulatory compliance.
WHO WE ARE: 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?
Powered by JazzHR