Senior Quality Engineer: GMP Validation & Compliance Lead

Quality Consulting Group, LLC; Juncos (PR); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Quality Consulting Group, LLC, a leader in the pharmaceutical, biotech, medical devices and manufacturing industry, is seeking a driven quality professional to join our team in Puerto Rico and the USA.

You will collaborate with engineering and manufacturing to maintain quality standards, develop validation strategies (IQ/CSV/OQ/PQ), and support regulatory compliance and change control. Availability for 1st shift is required.

Qualifications

• Expertise developing, reviewing, approving and executing validation strategies for equipment qualification (IQ/CSV/OQ/PQ).
• Strong knowledge of QMS, including change control and risk management.
• Experience ensuring FDA/ISO 13485 regulatory compliance.
• Experience with equipment and process validation in GMP environments.
• Audit-ready documentation experience.

Responsibilities

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into finished products.
• Collaborates with engineering and manufacturing to ensure quality standards.
• Designs inspection and testing mechanisms; conducts QA tests and statistical analysis.
• Ensures corrective actions meet reliability standards and docs comply.
• Specialize in design, incoming material, production control, product evaluation and reliability as needed.
• Equipment & Process Validation; Quality Systems & Change Control; Regulatory Compliance & Manufacturing Change Management.

Skills

4+ years experience

Validation strategies

QMS knowledge

Regulatory compliance

Equipment qualification

Education

Bachelor's degree in engineering

Job description

Quality Consulting Group, LLC, a leader in the pharmaceutical, biotech, medical devices and manufacturing industry, is seeking a driven quality professional to join our team in Puerto Rico and the USA.

You will collaborate with engineering and manufacturing to maintain quality standards, develop validation strategies (IQ/CSV/OQ/PQ), and support regulatory compliance and change control. Availability for 1st shift is required.