Engineer II, QA

Description

This is a quality engineering role supporting bioprocessing equipment automation products, manufacturing, and quality systems.

You will help products and processes meet customer, regulatory, and business requirements, and stay compliant with cGMP, ISO, FDA, and other applicable quality standards.

You will work with cross-functional teams to keep the business audit ready and to support its quality goals.

The company develops science solutions for problems such as environmental protection, food safety, and cancer research.

Responsibilities

• Handle CAPA, nonconformance, deviation, and change control work so issues close on time and meet regulatory rules.
• Check quality documents for accuracy, completeness, and compliance with the quality system.
• Help manage document control and keep quality records according to set procedures.
• Take part in internal audits, customer audits, and regulatory inspections.
• Help carry out corrective and preventive actions that improve product and process quality.
• Assist with IQ, OQ, and PQ for equipment, systems, and manufacturing processes.
• Review and approve validation protocols, qualification reports, and related paperwork.
• Join design reviews and take part in design verification, design validation, and design change work.
• Support FMEA and other quality engineering risk assessments.
• Assess equipment, process, and product designs for compliance, manufacturability, reliability, and quality.
• Lead or help with investigations into product, process, supplier, and customer quality problems.
• Run root cause analysis using methods such as Fishbone, 8D, and FMEA.
• Study quality metrics and trends to find improvement opportunities.
• Help put corrective and preventive actions in place and verify they work.
• Contribute to projects that raise product quality, compliance, and operational efficiency.
• Work with Engineering, Manufacturing, Validation, Supply Chain, Regulatory Affairs, and Operations to solve quality issues.
• Provide quality support for equipment, process, and product changes across the product lifecycle.
• Support investigations of customer complaints and supplier quality work.
• Share quality risks, investigation findings, and recommendations with stakeholders.
• Take on other duties assigned to support business goals, quality initiatives, and operations.

Requirements

• An advanced degree in engineering, life sciences, chemistry, biotechnology, or a related technical field with no prior professional experience, or a bachelor's degree in one of those fields with 2 years of experience in quality assurance, quality engineering, or quality systems in GMP or ISO-regulated settings, ideally in medical device, pharmaceutical, biotechnology, or bioprocessing.
• Hands-on experience with quality systems including CAPA, deviations, nonconformances, change control, and investigations.
• Experience supporting equipment, process, or system qualification and validation.
• Experience working with cross-functional engineering and manufacturing teams.
• Knowledge of cGMP, ISO 13485, 21 CFR Part 820, validation requirements, and applicable quality standards.
• Understanding of CAPA, deviations, nonconformance handling, change control, and customer complaint handling.
• Knowledge of design controls, design verification and validation, and risk management.
• Experience with IQ, OQ, and PQ.
• Knowledge of quality engineering tools such as FMEA, Fishbone, 8D, root cause analysis, and statistical quality methods.
• Strong analytical and problem-solving skills to assess quality data and recommend improvements.
• Strong technical writing for SOPs, validation protocols, qualification and investigation reports, and other technical documents.
• Working knowledge of Microsoft Office and quality management systems such as TrackWise, SAP QM, or similar.
• Strong organization, project management, and prioritization skills.
• Clear verbal and written communication, with the ability to work across Engineering, Manufacturing, Supply Chain, Validation, Regulatory Affairs, and Operations.
• Able to work independently and contribute within cross-functional teams.
• Careful attention to detail and a firm commitment to quality and compliance.
• Preferred: ISO 13485/FDA Lead Auditor certification.
• Preferred: ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent certification.
• Preferred: experience with bioprocessing equipment, automation systems, or Single-Use Technologies.
• Preferred: experience with design controls, risk management, and validation documentation.
• Preferred: experience using electronic Quality Management Systems (eQMS).
• Preferred: knowledge of bioprocessing equipment, automation systems, and Single-Use Technology products.
• Preferred: experience with statistical analysis software and quality metrics reporting.
• Preferred: familiarity with ERP systems such as SAP.
• Preferred: experience with data visualization tools such as Power BI.
• Preferred: foreign language proficiency to support global customers and suppliers.

Conditions

Standard Monday to Friday schedule.

On-site in Logan, UT.

Relocation assistance is not provided.

You must be legally authorized to work in the United States without sponsorship.

Cleanroom rules bar hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair, and similar items.

Adherence to all GMP safety standards is required.

Some degree of PPE is required, such as safety glasses, gowning, gloves, lab coat, or ear plugs.

The work combines office tasks with activity on the manufacturing floor in regulated production areas.

Expect frequent sitting for document review, validation, technical writing, and data analysis.

Expect regular standing and walking across manufacturing, engineering, warehouse, and laboratory areas.

Occasional bending, reaching, and light movement during qualification, investigations, and audits.

Occasional lifting of materials or equipment up to 25 pounds, with assistance when required.

Regular use of required PPE, including safety glasses, gloves, gowns, protective footwear, or other site-specific equipment.

Work in controlled manufacturing and cleanroom environments as required.

Exposure to manufacturing equipment and moderate noise levels.

Participation in customer audits, supplier visits, and cross-functional projects may be required.

Occasional domestic and international travel based on business needs.

The company is an equal opportunity employer and provides reasonable accommodations to applicants and employees with disabilities.