Quality Systems Program Manager - 103 at Flexible & Integrated Technical Services, LLC

, , -

Full Time

Start Date

Immediate

Expiry Date

04 Mar, 26

Salary

0.0

Posted On

04 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Risk Management, Critical Thinking, Project Management, Communication, Problem Solving, Negotiating, Conflict Resolution, Quality Assurance, Regulatory Compliance, Audit Preparation, Process Analysis, Corrective Actions, Team Leadership, Innovation, Customer Service, DMAIC, Process Mapping

Industry

Pharmaceutical Manufacturing

Description

For Scheduling services in the Quality area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor’s Degree in Engineering or Sciences and five (5) years of experience within the Medical Devices Industry. Bilingual: Spanish and English Soft Skills: Negotiating and Conflict Resolution skills Shift: 1st, 2nd, and according to business needs. Experience in: Risk Management/Critical Thinking Hands-on Experience on Projects/Scheduling for Medical Device manufacturing. Leading cross-functional team and leveraging solid PM skills (project planning, communication, risk management). Problem solving methodologies (DMAIC, process map, 5 whys). 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 of 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) Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. Works directly with operating entities to provide process analyses oversight, continuingly to enforce requirements and meet regulations. Leads audit and inspection preparation, resolution of audit and inspection findings, and liaises with auditing groups and inspectors through all stages. Prepares reports and/or necessary documentation (ex, Corrective and Preventive Actions) and provides to applicable stakeholders. Co-ordinates legal requests in support of government investigations or litigations. Ensures the quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of the company's mission globally. Is accountable for the overall program process, performance, and customer satisfaction. WHO WE ARE: We are a service provider company that is different from the rest. We pride ourselves on 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

The Quality Systems Program Manager oversees the development and maintenance of quality programs and ensures compliance with policies and regulations. They lead audit preparations, resolve findings, and coordinate legal requests in support of investigations.