Quality Engineer

We are seeking a detail-oriented and proactive Quality Engineer to provide quality assurance support across a range of manufacturing processes, including pharmaceutical products, medical devices, combination products, and biologics. This role plays a key part in driving strategic quality initiatives and ensuring compliance with regulatory and internal standards.

Key Responsibilities:

• Provide QA support across Product QA, Manufacturing QA, Supplier/Incoming QA, Process Qualification/Validation, Compendia Management, and CAPA.
• Lead and review process qualification (PPQ) activities, focusing on process controls and raw material controls.
• Ensure compliance with applicable regulations for drugs, biologics, devices, and combination products.
• Collaborate with cross-functional teams to plan, prepare, review, and approve quality documentation.
• Maintain and improve the effectiveness of the quality system in alignment with internal policies and procedures.
• Participate in internal and external audits (e.g., FDA, EMA, Anvisa) and present relevant data.
• Support functions including R&D, Manufacturing Science & Technology (MST), Supply Chain, Program Management, Commercial, Medical, Pharmacovigilance, and Regulatory Affairs.
• Coordinate training, continuous improvement initiatives, and tactical support across teams and affiliates.
• Assist in new product introductions and design changes for medical devices and combination products.
• Conduct compliance assessments and implement improvements to address gaps in quality systems.
• Develop and manage training programs related to quality assurance practices.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• Experience in pharmaceutical, medical device, or biologics manufacturing environments.
• Strong understanding of regulatory requirements and quality systems.
• Excellent communication and collaboration skills.
• Experience with process validation and PPQ is highly desirable.

Pay and Benefits

The pay range for this position is $60.00 - $65.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Worcester,MA.

Application Deadline

This position is anticipated to close on Aug 15, 2025.