Senior Quality Engineer (Medical Device)

Be Seen and Heard at EyePoint

At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we’re taking in business fuels our success for:

• preventing blindness through vision-saving medications
• delivering best-in-class proprietary pharmaceutical technologies
• transforming ocular drug delivery

We See You.

• Your wellbeing
• Your professional worth
• Your future at EyePoint

EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There’s space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected.

This person will report directly to the Director of Quality Engineering and will be responsible for design assurance function of the Injector for EyePoint Combination Products.   Additionally, this role will be responsible for the quality oversight of qualification packages of manufacturing and/or laboratory equipment, evaluating and implementing protocols and methods to inspect and test in-process raw materials and finished products and ensure compliance with the regulatory requirements and the expectations of EyePoint. This role will also participate in reviewing and approving manufacturing trending data and GMP investigations.

This position is located at our Watertown, MA site. We offer a hybrid work schedule.

Primary responsibilities include, but are not limited to, the following:

Individual responsibilities

• Serve as a team member to provide quality engineering expertise to product Research and Development, Manufacturing Operations, Facilities, Quality Control and Engineering departments.
• Act as the Design Assurance lead on Injector development teams (e.g. core teams, risk management teams, manufacturing teams, etc.) to ensure that the appropriate documentation (DHF, DMR, Technical Documentation, etc.) is generated to support Combination Product submissions.
• Be a key contributor to the Quality Assurance function and provide leadership to all quality processes within the product lifecycle.
• Collaborate with the Device Engineering function in ensuring product development is properly documented and compliant with 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, and other applicable US FDA and EU MDR regulations, standards, and guidance.
• Be a primary reviewer of Design Transfer and Product Launch including in change assessment activities.
• Drive Risk Management processes and activities.
• Use of professional experience to resolve complex issues and achieve our goals creatively and effectively. This role requires a drive to own the function and the versatility to operate in a hands-on manner. This is the ideal role for a seasoned senior - level quality engineer who is seeking to own and influence the product design process throughout the product development process.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Identify areas for process improvement and provide supporting information for change, including reasons and justification.
• Responsible for part qualification of new/revised items as well as documentation for inspection/testing procedures
• Collaborate 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 design control process and Quality Engineering. The Quality Engineering subjects are Risk Management, Test Method Validation (TMV), Statistics, Reliability Engineering, Process Validation (PV).
• Develop processes and tests to determine that appropriate quality control analysis is being performed and documented.
• Support projects and organizational initiatives identified by Quality, including but not limited to line clearance and production inspection.
• All other duties as assigned.

Miscellaneous, Ongoing Responsibilities

• Perform analysis and identify trends in the inspection of finished products, in-process materials and bulk raw materials, and recommend corrective actions when necessary.
• Experience with FDA and ISO inspections and registration.
• Evaluate and analyze efforts in organizing, documenting and interpreting inspection support documents and records

Primary skills and knowledge required include, but are not limited to the following:

• Knowledge of basic statistical and engineering principles is essential.
• Ability to lead, communicate, interact and influence effectively at multiple technical levels across functions.
• Demonstrated capacity to work in a fast-paced environment with strong attention to detail.

Other Requirements:

• Working knowledge and practical application of 21 CFR Part 820/210/211/4, ISO 13485, ISO 14971.
• Practical knowledge and experience using Minitab or other statistical analysis tools.
• Understanding and application of Gage R&R and Measurement System Analysis desired
• Process validation experience, including IQ/OQ/PQ desired.
• Highly detail oriented with strong organization and prioritization skills.

Level of Education Required: Bachelor of Science

Number of Years of Experience in the Function and in the Industry:

Minimum 8 years of medical device quality assurance experience that includes a minimum of 5 years in design assurance

Envision Your Future

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.

The collective power of our values influences everything we do, and everything we do for you.

EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

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