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Senior Quality Engineer

Company: Portal Instruments
Location: Cambridge
Posted on: August 2, 2022

Job Description:

About PortalPortal aims to transform medicine by enabling patients to self-inject their biological drugs with a revolutionary needle-free device. This innovative drug delivery system is designed to replace auto-injectors and our early studies show it is overwhelmingly patient preferred. Issued from MIT Research and connected to the cloud, the Portal device allows biopharmaceutical companies to differentiate their therapies with a patient-centric drug-delivery solution. Join us on this exciting journey of making patient care and comfort a priority.At Portal we believe in workplace inclusion - all employees belong, contribute, and thrive in our fast-paced environment. All people need to be represented for all patients to be represented. We encourage you to apply no matter your background - because we understand a diverse culture formulates diverse solutions. Senior Quality EngineerReports to: Senior Director of Quality and RegulatoryOverviewWe're looking for a Senior Quality Engineer who is passionate about making a difference in the lives of patients and how medicines are delivered today. The Quality Engineer reports to the Senior Director of Quality and Regulatory and supports quality processes for medical device development and manufacturing at Portal Instruments. This person handles multiple projects and tasks, from product inception through manufacturing and product launch.The QE represents Quality on internal and external project teams for both design and manufacturing. This role also supports quality systems, product design verification & validation, medical device software validation, manufacturing process validation, customer feedback, corrections and removals and corrective and preventive action investigations and implementation.In this role you may be called upon to participate in the following areas:

  • Design Controls - Support Verification & Validation (test plans, protocols, reports), test method validation, Incoming Inspection, lot release of engineering, clinical and commercial devices, nonconforming product disposition, review of design documentation, calibration and equipment validation (IQ/OQ/PQ)
  • Quality Systems - Support continuous improvement of quality system procedures in accordance with 21 CFR 820, ISO 13485, EU MDR, MDSAP, and ISO 14971
  • Risk Management - Maintain the risk management file for Portal Instruments products throughout their lifecycle
  • CAPA - Participate with other team members in all aspects of Corrective and Preventive action process as required, including documentation of CAPA, root cause investigation, and implementation of improvement activities
  • Complaint Handling - Participate in complaint processing and trending, and failure investigations as needed
  • Management Review - Assist management representative in compiling and trending Management Review metrics
  • Supplier Management - Perform vendor audits and interact with vendors surrounding Supplier Corrective Action Requests (SCAR)
  • Audits - Conduct and/or participate in internal and external audits as needed
  • Software - Work with software team and support software development in compliance with IEC 62304
  • May be called upon to guide / manage junior engineers In the role you will need:
    • B.S. degree in Engineering, Science, or related discipline required. Master's degree in engineering or MBA a plus.
    • Minimum 5 years of experience. Experience in a medical device environment preferable, including experience with both design and manufacturing.
    • Strong working knowledge of 21 CFR 820, ISO 13485, and ISO 14971. Experience developing or modifying Quality Management Systems in accordance with these regulations is desired.
    • Knowledge and experience with MDSAP, EU MDR, IEC 62304, and ISO 60601 requirements a plus
    • Proven track record in new product development and commercialization, post-launch experience a plus
    • Experience working with contract manufacturers and establishing relationships with suppliers is a plus.
    • Knowledge of sterilization processes for medical devices a plus
    • Good communication skills, both written and oral.
    • Knowledge of statistical sampling and analysis
    • Possess a high sense of urgency, good judgement, creative problem solving, initiative and common sense.
    • Present a professional demeanor and demonstrate an ability to work effectively with a diverse group of individuals.
    • Must be energetic, work quickly and efficiently with detail and accuracy.
    • Must be able to effectively manage multiple priorities in a fast paced and dynamic environment.Working at PortalPortal Instruments offers employees the opportunity to work in a fast-paced start-up that values innovation, creativity, accountability, teamwork, and openness while providing excellent leadership and development opportunities. Which all sounds great--- right? But what about the other stuff??Pay
      • We believe in transparency so if your resume meets the job requirements, we will discuss salary range with you right from the start, so feel free to ask us!
      • Portal offers a competitive salary, a comprehensive benefits package, including stock options, both Roth and traditional 401(k) retirement plans, thoughtful health and dental plans and a chance to make a difference in the lives of thousands of patients.Healthcare for FTE:
        • Portal works very hard to select healthcare plans that keep costs low for employees while still maintaining the level of care you deserve and expect from leading healthcare companies. We even pay the first half of your deductible so that we can keep the premium costs low for you!
        • We offer both PPO and HMO healthcare plans, dental, orthodontic, vision and accident insurance plans too!
        • Paid family medical leave is covered by Portal both short- and long-term disability as well as AD&D insurance and all are 100% company sponsored
        • Did we mention employees are eligible for a variety of flexible spending accounts (FSA)?Vacation
          • 20 days of vacation for everyone, because everyone deserves to take a break and our team is encouraged to take all their time off each year to recharge!
          • 13 company-wide state and federal holidays and often a company-wide holiday shutdown - sometimes the best reward for hard work and results is no work and all rest!
          • If you're sick.. you're sick! And being sick is certainly no picnic (or vacation!), so all employees get sick days to use when they are under the weather. We want you to take care of yourself, plus staying home helps protect everyone! At Portal we want to make sure you know that our strong team has your back to support you through all of life's obstacles.Flexibility - We put flex in flexibility!
            • Life shouldn't just revolve around work - if you want to go exercise at 2 PM or grab lunch with an old friend, be our guest!
            • Portal works in a hybrid environment - whether you work from Florida or NYC, you're still a part of the Portal team. We are a results driven team - so we don't have to see a green dot on Slack to trust that you're doing your job!
            • Portal offers employee's an assistance program which includes confidential counseling, financial information and resources, work-life solutions, free online will preparation and more!
            • We also offer a commuter reimbursement account, dependent care accounts, on-site parking (subject to availability), a bike room and locker room with a shower!Growth at Work
              • We invest in your career. Our company's growing quickly, and we'll give you the opportunity to do the same. You'll have access to several professional development opportunities so that you can keep up with the company's evolving needs and grow your career along the way.
              • Portal offers its employees access to the Southern New Hampshire University discount program on part time tuition - a 10% employee discount for both undergraduate and graduate students More Benefits--- seriously!
                • Daily free lunch
                • Casual dress code
                • Pop-up wellness benefits
                • Happy hour
                • Annual company sponsored events
                • Volunteer opportunities
                • Annual donation match program though BrightfundsTo Apply: Please submit a resume and cover letter to: You will be contacted if your background meets Portal's needs.

Keywords: Portal Instruments, Cambridge , Senior Quality Engineer, Engineering , Cambridge, Massachusetts

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