How You Will Make an Impact:
The Quality Engineer II provides quality engineering support for bioprocessing equipment automation products, manufacturing and quality systems, ensuring products and processes consistently meet customer, regulatory, and business requirements. This role contributes to operational excellence by supporting validation and qualification activities, design control processes, quality investigations, and continuous improvement initiatives that enhance product quality, compliance, and manufacturing performance. The position ensures compliance with cGMP, ISO, FDA, and applicable quality standards while partnering with cross-functional teams to maintain audit readiness and support the business’ quality objectives.
Day In The Life:
Quality Systems & Compliance
- Support CAPA, nonconformance, deviation, and change control activities to ensure timely resolution and regulatory compliance.
- Review quality documentation to verify accuracy, completeness, and compliance with quality system requirements.
- Support document control activities and maintain quality records in accordance with established procedures.
- Assist with internal audits, customer audits, and regulatory inspections.
- Support implementation of corrective and preventive actions to improve product and process quality.
Validation, Qualification & Design Quality
- Support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for equipment, systems, and manufacturing processes.
- Review and approve validation protocols, qualification reports, and related documentation.
- Participate in design reviews, design verification, design validation, and design change activities.
- Support risk assessments using FMEA and other quality engineering methodologies.
- Evaluate equipment, process, and product designs for compliance, manufacturability, reliability, and quality requirements.
Investigation & Continuous Improvement
- Lead or support investigations involving product, process, supplier, and customer quality issues.
- Perform root cause analysis using structured problem-solving methodologies such as Fishbone, 8D, and FMEA.
- Analyze quality metrics and trends to identify opportunities for continuous improvement.
- Support implementation and verification of corrective and preventive actions.
- Participate in projects that improve product quality, compliance, and operational efficiency.
Cross-Functional Collaboration & Customer Support
- Partner with Engineering, Manufacturing, Validation, Supply Chain, Regulatory Affairs, and Operations teams to resolve quality issues.
- Provide quality support for equipment, process, and product changes throughout the product lifecycle.
- Support customer complaint investigations and supplier quality activities.
- Communicate quality risks, investigation findings, and recommendations to stakeholders.
- Perform other duties and responsibilities as assigned to support business objectives, quality initiatives, and operational requirements.
Education & Experience:
Required:
- Advanced degree in Engineering, Life Sciences, Chemistry, Biotechnology, or related technical field with no prior professional experience OR
- Bachelor's degree in Engineering, Life Sciences, Chemistry, Biotechnology, or related technical field with two years of experience in quality assurance, quality engineering, or quality systems within GMP/ISO-regulated environments, preferably medical device, pharmaceutical, biotechnology, or bioprocessing industries.
- Experience supporting quality systems including CAPA, deviations, nonconformances, change control, and investigations.
- Experience supporting equipment, process, or system qualification and validation activities.
- Experience collaborating with cross-functional engineering and manufacturing teams.
Preferred:
- ISO 13485/FDA Lead Auditor certification.
- ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent certification.
- Experience within bioprocessing equipment, automation systems, or Single-Use Technologies.
- Experience supporting design controls, risk management, and validation documentation.
- Experience using electronic Quality Management Systems (eQMS).
Knowledge, Skills, Abilities:
Required:
- Knowledge of cGMP regulations, ISO 13485, 21 CFR Part 820, validation requirements, and applicable quality standards.
- Understanding of quality systems including CAPA, deviations, nonconformance management, change control, and customer complaint handling.
- Knowledge of design control principles, design verification, design validation, and risk management processes.
- Experience supporting Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Knowledge of quality engineering tools including FMEA, Fishbone, 8D, root cause analysis, and statistical quality methodologies.
- Strong analytical and problem-solving skills with the ability to evaluate quality data and recommend improvements.
- Excellent technical writing skills for SOPs, validation protocols, qualification reports, investigation reports, and technical documentation.
- Proficiency with Microsoft Office applications and quality management systems such as TrackWise, SAP QM, or equivalent.
- Strong organizational, project management, and prioritization skills.
- Excellent verbal and written communication skills with the ability to collaborate effectively across Engineering, Manufacturing, Supply Chain, Validation, Regulatory Affairs, and Operations.
- Ability to work independently while contributing effectively within cross-functional teams.
- Strong attention to detail and commitment to quality and compliance.
Preferred:
- Knowledge of bioprocessing equipment, automation systems, and Single-Use Technology products.
- Experience with statistical analysis software and quality metrics reporting.
- Familiarity with ERP systems such as SAP.
- Experience with data visualization tools such as Power BI.
- Foreign language proficiency supporting global customers and suppliers.
Physical Requirements and Work Environment:
- Combination of office-based work and manufacturing floor activities within regulated production environments.
- Frequent sitting for documentation review, validation activities, technical writing, and data analysis.
- Regular standing and walking throughout manufacturing, engineering, warehouse, and laboratory areas.
- Occasional bending, reaching, and light physical movement while supporting equipment qualification, investigations, and audits.
- Occasional lifting of materials or equipment up to 25 pounds with appropriate assistance when required.
- Regular use of required PPE including safety glasses, gloves, gowns, protective footwear, or other site-specific protective equipment.
- Ability to work in controlled manufacturing and cleanroom environments as required.
- Exposure to manufacturing equipment, moderate noise levels, and GMP-regulated production environments.
- May require participation in customer audits, supplier visits, and cross-functional project activities.
- Occasional domestic and international travel based on business needs.
