Sr. Quality Engineer

Medial Group; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Medial Group in Juncos, PR seeks a Quality Assurance professional to develop, modify, and maintain quality standards across manufacturing processes. You will collaborate with engineering and production teams to implement inspection, testing, and validation methods while ensuring regulatory compliance.

The role requires 3–5 years in a regulated industry, knowledge of pFMEA and basic statistics (Minitab), and strong technical writing skills. Experience with medical device regulations is a plus.

Qualifications

• 3–5 years of experience in a regulated industry (Medical Devices, Pharma, or Biotech).
• Experience with Risk Management documentation (pFMEA).
• Basic knowledge of statistics (preferably using Minitab).
• Knowledge of validation strategy design (requirements flow-down from design to manufacturing).
• Bachelor in Engineering completed
• Experience in CAPA, investigations, and technical writing.
• Knowledge of Medical Device regulations.

Responsibilities

• Develop, modify, apply, and maintain quality standards in manufacturing.
• Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
• Develop and implement methods and procedures for inspecting, testing, and evaluating products and production equipment.
• Perform statistical analysis of product and process performance.
• Ensure documentation is compliant with regulatory requirements.
• May specialize in design, production control, product evaluation, and/or reliability as they apply to product or process quality.
• Perform and/or review process validation and equipment documentation, including URS, FAT, IQ, OQ, PQ, and TMV (excluding cleaning and laboratory processes).
• Support investigations of manufacturing operations events and assess manufacturing defects/rejects trends.
• Support design requirements validation and manufacturing controls for projects (not Operational Excellence initiatives).
• *Other duties may be assigned.*

Skills

Quality standards

Cross-functional collaboration

Statistical analysis

Regulatory documentation

Process validation

CAPA investigations

Technical writing

Medical Device regulations

Validation strategy design

Education

Bachelor in Engineering

Tools

Minitab

CSV (Computer System Validation)

Validation planning tools

Job description

Juncos, Puerto Rico

• Develop, modify, apply, and maintain qualitystandards.
• Collaborate with engineering and manufacturingfunctions to ensure quality standards are in place.
• Develop and implement methods and procedures forinspecting, testing, and evaluating products and production equipment.
• Perform statistical analysis of product/processperformance.
• Ensure documentation is compliant withregulatory requirements.
• May specialize in design, production control,product evaluation, and/or reliability as they apply to product or processquality.
• Perform and/or review process validation andequipment documentation, including URS, FAT, IQ, OQ, PQ, and TMV (excludingcleaning and laboratory processes).
• Support investigations of manufacturingoperations events and assess manufacturing defects/rejects trends.
• Support design requirements validation andmanufacturing controls for projects (not Operational Excellence initiatives).

*Other duties may be assigned.*

Requirements

• 3–5 years of experience in a regulated industry (Medical Devices, Pharma, or Biotech).
  
• Experience with Risk Management documentation (pFMEA).
  
• Basic knowledge of statistics (preferably using Minitab).
  
• Knowledge of validation strategy design (requirements flow-down from design to manufacturing).
  
• Bachelor in Engineering completed
  
• Experience in CAPA, investigations, and technical writing.
  
• Knowledge of Medical Device regulations.
  

Nice to Have

• Change Control of Medical Devices.
• Process Validation.
• Computer System Validation (CSV).
• Experience with Manufacturing, Packaging, and Laboratory Equipment.
• Technical troubleshooting experience.
• Background in Quality, Process Control, or Assurance within Medical Devices.
• Investigation and root cause analysis skills.
• Strong technical writing, organization, and communication skills.
• Experience developing/updating pFMEA, Control Plans, and Process Flows.
• Computer software programming knowledge.
• Advanced knowledge in Process Validation and CSV.