Quality Engineer III

Description

The company makes products for clinical and commercial manufacturing programs, and this role is an office-based individual contributor position on a standard Monday to Friday schedule.

You will sit in the Product Quality organization and support quality assurance across those programs, working with cross-functional teams to keep products compliant with regulatory requirements while contributing to operational excellence and continuous improvement.

You will bring technical expertise to quality investigations, quality system support, and process improvement, helping products consistently meet customer and regulatory expectations.

Responsibilities

• Provide quality assurance support for clinical and commercial manufacturing programs.
• Work with Manufacturing, Operations, Engineering, Validation, Regulatory Affairs, and other functional teams to keep work compliant with GMP and regulatory requirements.
• Review and approve GMP documents such as batch records, deviations, change controls, CAPAs, and validation documents.
• Lead quality investigations, carry out root cause analyses, and help put corrective and preventive actions in place that work.
• Analyse quality system data and metrics to spot trends and propose process improvements.
• Take part in risk assessments and quality planning across the product lifecycle.
• Support technology transfer and the introduction of new manufacturing processes.
• Take part in internal audits, customer audits, and regulatory inspections.
• Help drive continuous improvement that strengthens quality systems and operational performance.
• Keep your required training current and follow company policy, GMP regulations, and applicable quality standards.
• Carry out other duties as assigned.

Requirements

• Hold a bachelor's degree in engineering, life sciences, chemistry, or another scientific or technical discipline.
• Have either an advanced degree and 3+ years, or a bachelor's degree and 5+ years, of quality assurance experience in a regulated pharmaceutical, biotechnology, medical device, or related manufacturing setting.
• Have demonstrated experience supporting GMP quality systems and regulatory compliance.
• Have working knowledge of FDA, EMA, ICH, GMP, and other applicable regulatory requirements.
• Have experience with deviation investigations, CAPA management, change control, quality risk management, and document control.
• Have knowledge of validation and qualification activities.
• Bring strong analytical skills and root cause problem solving.
• Bring solid project management and organisational skills, and can prioritise several assignments in a fast-paced environment.
• Communicate well in writing and verbally, and collaborate effectively across multiple functional teams.
• Be proficient with Microsoft Office and quality management systems.
• Pay close attention to detail and be committed to quality.
• Show a customer focus, teamwork, a quality and compliance mindset, accountability and ownership, a drive for continuous improvement, technical problem solving, clear communication, and sound judgement.
• Optional: ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or another relevant quality certification.
• Optional: experience supporting biologics manufacturing or biopharmaceutical processes.
• Optional: experience with technology transfer and process validation.
• Optional: experience supporting customer audits and regulatory inspections.
• Optional: experience applying statistical analysis and quality metrics to drive continuous improvement.

Conditions

Standard Monday to Friday schedule, office-based.

You will work in a regulated GMP manufacturing environment and may interact with production, laboratory, warehouse, and office teams.

Occasional travel of up to 25% may be required.

You must be legally authorised to work in the United States now and in the future, without sponsorship.

Relocation assistance is not provided.

The company is an equal opportunity employer.

Benefits

• Competitive pay, an annual incentive plan bonus, healthcare, and a range of employee benefits.
• The company describes its culture as built on integrity, intensity, involvement, and innovation, with career and development prospects.