Senior Quality Engineer
Company: Portal Instruments
Posted on: August 1, 2022
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
We're looking for a Senior Quality Engineer who is passionate about
making a difference in the lives of patients and how medicines are
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
- 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
- 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
- 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
- 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
Which all sounds great--- right? But what about the other
- 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%
- Did we mention employees are eligible for a variety of flexible
spending accounts (FSA)?
- 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
- 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 Brightfunds
To Apply: Please submit a resume and cover letter to:
firstname.lastname@example.org. 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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