Quality Engineer

LHH Recruitment Solutions has partnered with a growing organization, and they are seeking a motivated Quality Engineer -- Medical Device / Pharmaceutical Manufacturing to join their team. This is an outstanding opportunity for a quality professional who enjoys building processes, driving continuous improvement, and making a measurable impact within a dynamic, entrepreneurial environment. If you thrive in organizations where your expertise is valued, your voice is heard, and you have the opportunity to influence quality systems and compliance initiatives, this role offers significant career growth and visibility.

The Quality Engineer will play a key role in supporting quality management activities across the organization, including investigations, complaint handling, CAPA management, non-conformance processes, validation activities, and quality documentation control. This individual will work cross-functionally to strengthen quality systems, ensure regulatory compliance, and support ongoing process improvement initiatives. This position is ideal for a candidate who enjoys hands-on problem solving, process development, and working within a fast-paced growth environment.

Key Responsibilities:

• Support quality system activities including investigations, validations, audits, and continuous improvement initiatives.
• Lead and participate in complaint investigations, non-conformance reviews, and corrective/preventive action (CAPA) processes.
• Review, revise, and maintain quality procedures, work instructions, SOPs, and controlled documentation.
• Partner with cross-functional teams to identify quality risks, implement corrective actions, and improve operational performance.
• Assist in managing regulatory and quality system changes to ensure ongoing compliance.
• Support quality validation activities related to products, processes, and systems.
• Analyze trends and quality metrics to identify opportunities for improvement.
• Participate in internal audits and support external regulatory or customer audits as needed.
• Contribute to quality system enhancement projects, including future electronic Quality Management System (eQMS) implementation initiatives.
• Promote a culture of quality, compliance, accountability, and continuous improvement throughout the organization.

Qualifications and Skills:

• Bachelor’s Degree in Engineering, Life Sciences, Quality, Manufacturing, or a related technical discipline.
• ASQ Certification (CQE, CQA, or related certification) is preferred.
• Minimum of 2 years of experience in a Quality function within the medical device, pharmaceutical, or highly regulated healthcare industry.
• Experience with quality validation activities, quality systems management, documentation control and SOP development, complaint handling processes, CAPA (Corrective and Preventive Actions), and non-conformance investigations and resolution.
• Knowledge of regulated manufacturing environments and quality system requirements.
• Strong technical writing, documentation, and communication skills.
• Proven ability to work independently and manage multiple priorities.
• Experience supporting or implementing an electronic Quality Management System (eQMS).
• Working knowledge and practical application of 21 CFR Part 820, 21 CFR Part 803, ISO 13485, and familiarity with ISO 14971, including Device Master Record (DMR) requirements and design controls.
• Familiarity with FDA-regulated environments and industry quality standards.
• Experience participating in audits and regulatory inspections.
• Continuous Improvement or Lean Manufacturing experience.

Compensation Range: $80,000 - $95,000

Benefits Offered: 2 weeks of vacation, paid sick leave where applicable by state law, Medical Insurance, Dental Insurance Vision Insurance, 401K, and Life Insurance.

If you are a passionate Quality Engineer looking for a new and rewarding career, please apply today! You don’t want to miss out on this opportunity!

LHH is a leader in permanent recruitment—and in the placement of top talent. Our areas of specialty include office administration, customer service, human resources, engineering, and supply chain and logistics. Please feel free to check us out and apply for other opportunities if this role isn’t a perfect match.

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act

• Los Angeles City Fair Chance Ordinance

• Los Angeles County Fair Chance Ordinance for Employers

• San Francisco Fair Chance Ordinance