"Professional working environments, with the personal and professional treat that only
EQVAL brings to consultants and employees!"
We are currently looking for professionals able to serve and share our Company Mission, for the following
LONG-TERM OPPORTUNITIES in Puerto Rico. (Full Time Employees and/or Professional Services contracts):
EHS Specialist
(PR North)
Responsibilities:
- Ensure compliance with internal procedures & EHS requirements.
- Administer environmental programs emissions control, hazardous and non-hazardous waste management and environmental permits.
- Lead and support sustainability initiatives Zero Waste, waze minimization, recycling and environmental improvement programs.
- Serve as liaison with environmental regulatory agencies (EPA, EQB, DNER, PRASA).
- Coordinate with emergency response agencies environmental incidents, spills, emissions and related scenarios.
- Conduct EHS audits, incident investigations, root cause analysis and environmental/occupational risk assessments.
- Provide EHS Training programs in new employee orientation and site wide awareness..
Qualifications:
- 5+ years of experience in EHS for the manufacturing regulated industry.
- Bachelor’s Degree in Science, Engineering, Occupational Safety, Environmental Health, Industrial Hygiene or related.
- Experience conducting risk assessments, incident investigations, workplace inspections, hazard identification and corrective / preventive actions.
- Experience supporting Occupational Health & Safety Management System compliance, audits, corrective actions and continuous improvement initiatives.
- Experience with ergonomic programs workstation assessments, ergonomic evaluations and implementation of corrective actions.
Design Automation Engineer
(PR East)
We are seeking a motivated and detail-oriented Design Automation Engineer to support the design, development, and implementation of small-scale automated equipment and systems.
Responsibilities:
This role will involve contributing to the design and programming of PLCs, assisting in the integration of vision systems, and supporting robotic automation projects to improve manufacturing processes.
The candidate will also assist in creating CAD models, wiring schematics, and ensuring compliance with safety and quality standards.
The ideal candidate should have a strong foundation in automation technologies and a willingness to learn and grow while collaborating with cross-functional teams in a dynamic environment.
Requirements:
- Education Required: Mechanical or Electrical EngineeringYears’
- Experience Required: 2-5 years
- Basic to intermediate experience in programming and troubleshooting PLCs (e.g., Siemens, Allen-Bradley) with a focus on learning advanced techniques..
- Familiarity with vision systems (e.g., Cognex, Keyence) and robotics (e.g., FANUC, ABB), with the ability to assist in system integration and troubleshooting.
- Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and basic knowledge of electrical wiring and schematics, with a desire to expand design capabilities.
Purchasing Agent
(PR -East)
The Purchasing Agent supports procurement activities by managing purchasing processes, resolving invoice discrepancies, and coordinating with suppliers and internal teams to ensure accurate and timely transactions.
Key Responsibilities:
- Serve as the main point of contact for reviewing and resolving invoice discrepancies..
- Manage Credit Hold and ShipmentHold requests through ServiceNow or similar systems.
- Process price change requests when discrepancies exist between Purchase Orders and invoices.
- Collaborate with Supply Chain Planners/Buyers to resolve issues efficiently.Review supplier statements of account and communicate updates directly with vendors, including regular follow-ups as needed.Work closely with Accounts Payable to ensure timely processing and release of payments.
Qualifications:
- Bachelor’s degree required (Supply Chain, Business, or related field preferred experience is most critical).
- Experience in purchasing/buying roles. SAP or ERP system experience required.
- Strong experience handling invoice discrepancies.
- Fluent in English (speaking, reading, and writing).
Microbiologist Sterilization
(PR East)
Requirements:
- Bachelor’s Degree in Science (Microbiology or Biology preferred).
- 3–5 years of experience in the Medical Device industry.
- Strong knowledge of microbiology and sterilization processes.
- Experience with testing bench, bioburden, and endotoxins (LAL).
- Fully bilingual (English/Spanish).
- Experience with Non-Conformance investigations.
- Knowledge of Sterility Assessment
Responsibilities:
- Perform microbiological, chemical, and biological testing on raw materials, in-process, and finished products.
- Prepare, clean, disinfect, and sterilize instruments, materials, and supplies.Follow established protocols and regulatory requirements for handling and testing.
- Analyze and interpret test results, ensuring accuracy and compliance with specifications.
- Recommend and implement corrective actions when needed.
- Develop, validate, and improve controlled environment and analytical methods.
- Utilize standard and advanced laboratory instrumentation for qualitative and quantitative analysis.
- Support method transfers from R&D when applicable.
Process Engineer
(PR East/ PR South)
Will support manufacturing operations on a Medical Device environment by ensuring equipment and processes meet quality and efficiency standards. This role requires expertise in validation, troubleshooting, and equipment commissioning, while collaborating with cross-functional teams to implement improvements and maintain regulatory compliance.
Minimum Requirements:
- Bachelor’s degree in Engineering (required).
- Minimum of 4 years of relevant experience, or advanced degree with at least 1 year of experience.
- Proficiency in validation processes, including Process Validation (PV) and Computer System Validation (CSV).Experience with change control in medical devices.
- Experience in equipment commissioning and qualification.
- Strong troubleshooting skills and experience with equipment setups.
- Proficiency in document management.
- Background in quality, process control, and assurance within the medical device industry.
- Strong organizational, analytical, and communication skills.
- Ability to work collaboratively with cross-functional teams.
Responsibilities:
- Provide technical and sustaining engineering support in manufacturing operations.
- Recommend and implement equipment and process modifications to meet quality standards, improve production efficiency, and increase yields.
- Integrate equipment and material capabilities to meet process and technology specifications.
- Review product development requirements for compatibility with processing methods, cost, and schedule considerations.
- Collaborate with product design and development teams to ensure processes and designs are aligned.
- Lead innovation, development, and optimization of manufacturing processes, from feasibility to implementation.
- Conduct statistical analysis and ensure processes are compatible with statistical process control techniques.
- Ensure compliance with industry regulations, validation protocols, and internal quality standards.
Validation Engineer / Specialist
(PR- West / PR South)
Validation Engineer/Specialist is required to support Validation/Qualification activities in a Medical Devices manufacturing environment.
Minimum Requirements:
- Bachelor Degree in Engineering Field (Mechanical, Electrical, Industrial Engineers preferred).
- Knowledge in 21 CFR Part 820 regulation.
- Experienced (3-5 years) in the development and execution of validation documentation and protocols, including Validation Assessments, Validation Plans, Requirements Specifications (URS, FRS), IQ, OQ, PQ and Reports.
- Experience developing and implementing Measurement System Analysis (MSA), including Attribute Analysis, GR&R, DOEs.Project management skills required.
- Fully bilingual (English and Spanish).
- Experience in Minitab (software statistical tool).
- Good technical writing skills.
Supplier Quality Engineer
(PR South)
Responsibilities:
- Ensures that suppliers deliver quality parts, materials, and services.
- Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
- Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
- Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
- Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
- Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: Provides
- Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the ComponentEngineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow to provide customers with the highest quality and reliable products.
- Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
- Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
- Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.
Minimum Requirements:
- Education Required: Bachelors degree required in Engineering
- Years’ Experience Required: 3 years of experience required
- Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
Quality Engineer / Quality Application Specialist
(PR East- PR South)
The Quality Engineer and Quality Application Specialist will support manufacturing operations in a regulated medical device environment, with a primary focus on validations, investigations, and risk management activities. This role requires close collaboration with Engineering, Manufacturing, and Quality teams to ensure compliance, product quality, and the successful execution of projects aligned with regulatory standards.
Minimum Requirements:
- Bachelor’s degree in Engineering (Mechanical, Electrical, or Chemical preferred)
- 3–5 years of experience in Quality or Engineering (excluding laboratory) within a regulated industry.
- Experience with risk management documentation (pFMEA).
- Basic knowledge of statistics (Minitab)
- Experience designing validation strategies (requirements flow-down from design to manufacturing).Hands-on experience investigating manufacturing operations events to support product disposition.
- Experience assessing and tracing manufacturing defect/reject trends.
- Experience performing and/or reviewing process and equipment validations (URS, FAT, IQ, OQ, PQ, TMV) – excluding laboratory and cleaning.
- Strong knowledge of medical device regulations (FDA, ISO 13485, EU MDR).
- Experience with projects involving design requirements validation and manufacturing controls (not Operational Excellence initiatives).
- Expertise in CAPA, investigations, root cause analyses, and technical writing.
- Strong critical thinking and problem-solving skills with a focus on risk management (pFMEA).
- Experience in process and computer system validations.
Responsibilities:
- Lead and support nonconformance investigations, root cause analysis, and CAPA implementation.
- Review and execute validation protocols for manufacturing processes and equipment (URS, FAT, IQ, OQ, PQ, TMV).
- Analyze yield, defect, and trend data to identify quality issues and drive improvements.
- Develop, assess, and maintain pFMEAs for suppliers and manufacturing processes.
- Collaborate with cross-functional teams to ensure validation and risk management compliance throughout the product lifecycle.
- Review, develop, and maintain quality documentation in alignment with regulatory and internal requirements.
- Support projects involving design requirements validation, manufacturing controls, and process improvements.
- Apply statistical methods (SPC, Minitab) to monitor and enhance product and process performance.
- Investigate customer complaints, determine root causes, and recommend corrective actions.
Manufacturing Engineer
(PR East/ PR South / PR West)
The Manufacturing Engineer must have experience on Medical Device or Pharmaceutical industries, will focus on executing validation (IQ, OQ, PQ) and optimizing manufacturing processes. This role involves troubleshooting, improving production efficiency, and ensuring compliance with regulatory standards in a fast-paced environment.
Responsibilities:
- Lead and execute validation activities for equipment and process changes, including IQ, OQ, PQ, and associated documentation.
- Design and optimize manufacturing processes, ensuring efficient production layouts, material handling, and tool fabrication.
- Troubleshoot and improve production equipment and processes to enhance operational efficiency and product quality.
- Collaborate with cross-functional teams to support investigations (NCRs, Complaints) and implement corrective actions.
- Ensure compliance with regulatory standards (cGMP) in all manufacturing processes and validation activities.
Minimum Requirements:
- Bachelor’s degree in an Engineering field.
- Proven experience in developing and executing validation documentation, including Validation Plans, URS, FRS, IQ, OQ, PQ, and related reports.
- Hands-on experience in FDA inspections, ISO certifications, audits, and change control, non-conformance, and CAPA processes.
- Strong knowledge and experience in cGMP for Medical Device manufacturing environments.
- Proficiency in statistical analysis (GR&R) and data management, including tools like Minitab.
- 1-3 years of experience in areas such as investigations (NCRs, Complaints, CAPA), Lean Manufacturing, and Six Sigma tools.
- Experience with pFMEA (analysis and development) and its application.
- Fully bilingual (English and Spanish) with exceptional communication skills, both spoken and written.
- Expertise in Measurement System Analysis (MSA), including Attribute Analysis, GR&R, and Design of Experiments (DOE).
- Proficient in Microsoft Word, Excel, PowerPoint, and Minitab.
- Availability for 2nd shift and 3rd shift.
Personal Traits:
- Highly motivated, self-starter with the ability to handle multiple tasks and meet deadlines.A
- problem solver who thrives in a fast-paced, dynamic environment.
- Excellent interpersonal skills with the ability to collaborate effectively across teams.
BE PART OF THE EQVAL WORK TEAM!
How to apply? Send your resume to info@eqvalpr.com
