Quality Engineer II (Contract)
Location: Marlborough, MA (Onsite/Hybrid based on business needs)
Type: Contract (6 Months)
Compensation: 40-45/hr W2
About the Opportunity
A growing life sciences manufacturing organization is seeking a Quality Engineer II to support quality excellence across new product development, manufacturing transfer, and commercial operations. This individual will serve as a key quality partner, collaborating with engineering, manufacturing, product development, and operations teams to ensure products meet quality, regulatory, and customer requirements throughout the product lifecycle.
Key Responsibilities
- Support quality engineering activities for new product development and product lifecycle management.
- Apply design control and validation principles to product and process development activities.
- Participate in risk management activities, including FMEA and risk assessments.
- Collaborate with cross-functional teams to support product transfers and manufacturing readiness.
- Review and maintain development documentation and quality records.
- Support design verification, process verification, and test method development activities.
- Review qualification and validation documentation, including IQ/OQ/PQ protocols and reports.
- Investigate quality issues, nonconformances, deviations, and customer complaints.
- Participate in root cause investigations and corrective/preventive action initiatives.
- Support change control processes and quality review board activities.
- Drive continuous improvement initiatives using Lean and Six Sigma methodologies.
- Assist with internal audits and quality system compliance activities.
Required Qualifications
- Bachelor's degree in Engineering, Biological Sciences, Physical Sciences, or a related technical discipline.
- Minimum 5 years of Quality Engineering experience in a regulated manufacturing environment.
- Experience supporting new product development and commercialization activities.
- Knowledge of design controls, validation, risk management, and quality systems.
- Experience with FMEA, CAPA, change control, and deviation investigations.
- Familiarity with ISO 9001 or comparable quality management systems.
- Strong problem-solving, organizational, and communication skills.
- Ability to work effectively within cross-functional teams and manage multiple priorities.
Preferred Qualifications
- ASQ Certified Quality Engineer (CQE) or equivalent certification.
- Experience in biotechnology, pharmaceutical, medical device, or life sciences manufacturing.
- Knowledge of validation and qualification activities (IQ/OQ/PQ).
- Exposure to bioprocessing operations, filtration, chromatography, or related manufacturing technologies.
- Internal auditing experience.
- Lean Six Sigma training or certification.
Benefits of the Opportunity
- High-impact role supporting innovative product development and manufacturing initiatives.
- Exposure to cross-functional engineering and quality teams.
- Opportunity to contribute to process improvements and product launches.
- Fast-paced environment with meaningful project ownership and visibility.
