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Flexible & Integrated Technical Services

Integrated CQV, compliance, and engineering services.

Supplier Quality Engineer 2

Full-TimePosted on 8/3/2026
No salary listed
Mid
Bachelor's
Puerto Rico
In Person
Manufacturing Quality & TestQuality Engineering

About the job

Requirements
  • A bachelor's degree in Engineering and three years of experience within the medical devices industry are required.
  • Bilingual proficiency in Spanish and English is required.
  • Writing and communication skills are required.
  • Computer proficiency is required.
  • Experience with problem-solving techniques and root cause analysis is required.
  • Experience with process validation and computer software is required.
  • Must be able to work the first shift and according to business needs.
Responsibilities
  • Ensure that suppliers deliver quality parts, materials, and services.
  • Qualify suppliers according to company standards and potentially administer a Certified Supplier Program in receiving inspection to ensure cost-effectiveness.
  • Monitor parts from acquisition through the manufacturing cycle and communicate and resolve supplier-related problems as they occur.
  • Develop and prioritize an auditing schedule to ensure designated suppliers are audited regularly and meet good manufacturing practices and quality standards.
  • Evaluate suppliers' internal functions to assess overall performance and provide feedback on their operations.
  • For some individuals, provide Pre-Market Quality Engineering support to New Product Development in partnership with the Component Engineering and Post-Market Supplier Quality teams to deliver quality parts, materials, and services, prevent defects, and support reliable products.
  • Provide technical guidance and quality compliance for Supplier Quality engagement throughout the New Product Development lifecycle on newly qualified parts, implementing strategies to drive product quality and continuous improvement and ensuring purchased products and components are manufactured and qualified according to applicable industry standards, regulatory requirements, and customer requirements.
  • Collaborate with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, coordinate the Approved Supplier List, deploy Supplier Owned Quality, and develop Control Plans for new products.
  • Define receiving inspection requirements as needed and validate associated test methods for all internal Medtronic test methods.

About the company

F

Flexible & Integrated Technical Services

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FITS, LLC provides integrated engineering, compliance, and technical services to pharmaceutical, biotech, medical device, and healthcare organizations in Puerto Rico. It covers commissioning, qualification and validation (CQV), utilities and facilities engineering, maintenance, EHS, automation, and technical staffing to help clients maintain FDA-compliant operations and improve performance of mission-critical systems. Acting as an extension of client operations, FITS delivers turnkey projects, regulatory readiness, quality assurance, and continuous improvement with a multidisciplinary team to support site expansions and ongoing operations. Its goal is to help life-sciences and healthcare facilities scale safely and efficiently while ensuring reliable, compliant operations.

Company Size

51-200

Company Stage

Growth Equity (Non-Venture Capital)

Total Funding

$8M

Headquarters

Aguada, Puerto Rico

Founded

2008

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Simplify's Take

What believers are saying

  • FITS posted active 2026 openings in validation, C&Q, project management, and process development.
  • Its 2026 jobs span Juncos, Dorado, Yauco, and Juana Díaz, signaling broad demand.
  • Federal contractor registration with SAM.gov expands access to government-funded facilities work.

What critics are saying

  • FITS depends on contract hiring, exposing revenue to client shutdowns and procurement delays.
  • Heavy concentration in Puerto Rico life sciences ties FITS to local plant expansions and slowdowns.
  • A rival integrator winning Amgen or J&J accounts would immediately compress FITS utilization.

What makes Flexible & Integrated Technical Services unique

  • FITS embeds CQV, utilities, and technical staffing inside Puerto Rico regulated plants.
  • Clients include Amgen, Lilly, Bristol Myers Squibb, Abbott, Johnson & Johnson, and CooperVision.
  • Founded 2008, FITS combines engineering, maintenance, and validation under one local service platform.

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Benefits

Flexible Work Hours

Growth & Insights

Headcount

6 month growth

-10%

1 year growth

-10%

2 year growth

-10%
INACTIVE