EyePoint · 9 hours ago
Senior/Quality Engineer
Northbridge, MA
Full-time
Hybrid
Mid, Senior Level
$95K/yr - $158K/yr
3+ years expEyePoint is an ophthalmology company committed to preventing blindness through innovative therapeutics. They are seeking a Senior Quality Engineer who will oversee drug product validation and qualifications, ensuring compliance with regulatory requirements and facilitating quality engineering expertise across various departments.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Serve as a team member to provide quality engineering expertise to product Research and Development, Manufacturing Operations, Facilities, and Engineering departments
Maintain company compliance to in-house and/or external specifications and standards (i.e. GxP, ISO, ANSI, etc…)
Partner with Development and Engineering departments and ensure that drug process development requirements are being met in an effective manner to achieve quality by design, including those for process verification, validation, specification and procedure development, risk management, and process review
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Identifies areas for process improvement and provides supporting information for change, including reasons and justification
Collaborates in the development or modification of validation packages and deliverables, including, assessments (including risk assessments, e.g., FMEAs), plans, requirements, and protocols
Act as a subject matter expert on Risk Management, Test Method Validation (TMV), Statistics, Reliability Engineering, Process Validation (PV)
Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
Recommend and review processes and tests to determine that appropriate quality control analysis is being performed
Support projects and organizational initiatives as identified by management Quality ass activities as required including but not limited to line clearance and production inspection
Participate in risk analysis associated with but not limited to Corrective and Preventative Action (CAPA), Change Control, complaint investigation, failure investigation and hazard assessment processes
Execute and review data analysis, process capability assessments, sampling plans, and statistical evaluations for validation outcomes
Maintain the validated state of systems through periodic review and requalification programs
Contribute to continuous improvement initiatives, including optimization of validation approaches, templates, and lifecycle documentation practices
All other duties as assigned
Qualification
Required
Experience in the pharmaceutical industry, Medical Device / Combination Products a plus. Experience in process / equipment qualifications
Maintains current knowledge of global regulatory agency trends and drives implementation of related improvements throughout Operations and R&D work groups. Maintains current expertise in all related external regulatory requirements, technology, and internal systems, processes and procedures
Has wide ranging experience and is able to use Quality concepts and company objectives to resolve complex issues in an effective manner
Extensive knowledge of US and EU cGMP regulations and guidance
Proactively seeks to affect change to provide an inspection readiness state and reduce the number of observations identified during audits/inspections conducted
Oversees the creation and maintenance of compliance metrics, development of trend data of audit/inspection observations and communication of results expediently to applicable groups
Collaborate with the Manufacturing Quality organization and serves as a technical/regulatory resource for R&D and QC
Strong technical expertise of QA/QC and Manufacturing processes to facilitate development and maintenance of cGMP compliant quality systems
Actively promotes safety rules and awareness. Demonstrates sound safety practices at all times including appropriate use of protective equipment. Reports and takes initiative to correct safety and environmental hazards
Provides consistently prompt, efficient, dependable, highly skilled service
Demonstrates consistent judgment, quality, accuracy, speed, and creativity
Detects and resolves problems; assists others with problem resolution; misjudgment may jeopardize compliance
Takes initiative in making improvement suggestions to promote operational goals on a consistent basis
Active team member with broad exposure within as well as outside of company
Recommend improvements to on-going processes and projects
Facilitates designing processes with Quality built in from the beginning. Handles most out-of-compliance situations
High level of professional competence
Strong communication skills, collaborative teammate, motivated and passionate about finding solutions
Strong awareness of quality issues
Bachelor of Science in relevant field (Science /Engineering)
3 - 7 years of cGMP experience required; Quality Engineering roles strongly preferred
Preferred
ASQ (American Society for Quality) and/or ISO certification as a Certified Quality Engineer preferred
Experience with production of pharmaceutical products in an ISO7 cleanroom environment including knowledge of gowning practices, cleanroom behaviors and aseptic techniques
Compliance investigation experience preferred
Company
EyePoint
EyePoint (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to improve the lives of people with serious retinal diseases.
51-200 employees
H1B Sponsorship
EyePoint has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (4)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$803.8MKey Investors
Silicon Valley BankOcumension TherapeuticsEssex Woodlands Healthcare Partners
2025-10-14Post Ipo Equity· $150M
2023-12-05Post Ipo Equity· $215.9M
2022-03-09Post Ipo Debt· $45M
Leadership Team
Paul Ashton
President, Chief Executive Officer and a Director
D
Diane Shay
Vice President of Quality
Recent News
Clinical Trials Arena
2026-01-11
2025-12-17
2025-12-16
Company data provided by crunchbase