-
Control System Engineer
3 weeks ago
Engtal Billerica, United StatesMy client is seeking a Senior Systems Simulation Engineer to support our fuel cell engine development programs. This role will be responsible for owning and developing internal simulation suites accelerating development, understanding, and ultimately verification of new fuel cell ...
-
Electrical Systems Engineer
3 weeks ago
Michael Page Billerica, United StatesThe Electrical Systems Engineer will lead development efforts of the product system accessories. This is a hands-on position that will provide the opportunity for the right individual to build and manage a team. · Client Details · The organization is the emerging catheter mappi ...
-
Systems Manufacturing Engineer
3 weeks ago
Teledyne Technologies Billerica, United StatesThis position is for a Systems Manufacturing Engineering for new products being transitioned into operations and responsible for technical issues regarding exiting products being built in production. Work with the Mfg. Eng team and with the engineeri Manufacturing Engineer, Manuf ...
-
Principal Systems Engineer
2 weeks ago
00184 Leidos Security Detection & Automation, Inc. - Infor Tewksbury, United States Full timeLeidos is seeking a Systems Engineer to support our ProVision checkpoint products, including next-generation developments. The ProVision is the world's leading personnel scanner, found in airports around the world. · The successful applicant will be responsible for technical pla ...
-
Systems Engineer
3 weeks ago
Instrumentation Laboratory Company Bedford, United StatesThe R&D Professional Development Program (PDP) is a rotational program that exposes high potential individuals, with a passion for engineering and product innovation, to the exciting world of specialized diagnostics. As a worldwide leader in speciali Systems Engineer, Program, Pr ...
-
Control Systems Engineer II
11 hours ago
Nuvera Fuel Cells Billerica, United StatesJob Title · Control Systems Engineer II · Job Family · Job Description · Join Nuvera Fuel Cells, LLC, a trailblazer in sustainable innovation manufacturing fuel cell engines for on- and off-road vehicles and equipment, port and maritime applications, and stationary and portab ...
-
Control Systems Engineer II
3 weeks ago
Hyster-Yale Material Handling, Inc. Billerica, United StatesJob Title · Control Systems Engineer II · Job Family · Job Description · Join Nuvera Fuel Cells, LLC, a trailblazer in sustainable innovation manufacturing fuel cell engines for on- and off-road vehicles and equipment, port and maritime applications, and stationary and portable ...
-
System engineer
3 weeks ago
BlueNova Industries Gloster, United StatesYour job profile: · You are responsible for ensuring a coordinated concept including design, evaluation and analysis for the architecture of high-voltage battery systems, taking into account customer requirements. · You are responsible for adhering to the cost framework and man ...
-
Systems Engineer
1 day ago
Nuvera Fuel Cells, LLC Billerica, United States Paid WorkJob Title · Systems Engineer - Functional Safety Engineer · Job Family · Functional Engineering · Job Description · Nuvera Fuel Cells, LLC is a manufacturer of heavy-duty, zero-emissions hydrogen fuel cell stacks and engines for mobility applications. With facilities located in t ...
-
IT System Engineer
1 week ago
Titan Industries Watertown, United StatesAbout the Company · For over 30 years, InterConnect has been all about IT: As a system house, we support our customers with IT services and our IntelliOnline software simplifies the work of associations and organizations. · What sets us apart: a friendly team, a respectful work a ...
-
Sr Systems Engineer
3 weeks ago
Workday Tewksbury, United StatesAre you ready for a rewarding and inspiring career? · Unleash your potential · At Leidos, · where we deliver innovative solutions through the efforts of our diverse and talented people who are dedicated to our customer's success. We empower our teams, contribute to our communi ...
-
Systems Engineer II
2 days ago
Raytheon Technologies Tewksbury, United StatesDate Posted: · Country: · United States of America · Location: · MA131: Tewksbury, MA Bldg 1 Assabet 50 Apple Hill Drive Assabet - Building 1, Tewksbury, MA, 01876 USA · Position Role Type: · Onsite · At Raytheon, the foundation of everything we do is rooted in our values ...
-
Senior Systems Engineer
2 days ago
Raytheon Technologies Tewksbury, United StatesDate Posted: · Country: · United States of America · Location: · MA131: Tewksbury, MA Bldg 1 Assabet 50 Apple Hill Drive Assabet - Building 1, Tewksbury, MA, 01876 USA · Position Role Type: · Onsite · At Raytheon, the foundation of everything we do is rooted in our values ...
-
Senior Systems Engineer
11 hours ago
Raytheon Tewksbury, United StatesDate Posted: · Country: · United States of America Location: · MA131: Tewksbury, MA Bldg 1 Assabet 50 Apple Hill Drive Assabet - Building 1, Tewksbury, MA, 01876 USA Position Role Type: · Onsite At Raytheon, the foundation of everything we do is rooted in our values and a hig ...
-
Systems Engineer II
11 hours ago
Raytheon Tewksbury, United StatesDate Posted: · Country: · United States of America Location: · MA131: Tewksbury, MA Bldg 1 Assabet 50 Apple Hill Drive Assabet - Building 1, Tewksbury, MA, 01876 USA Position Role Type: · Onsite At Raytheon, the foundation of everything we do is rooted in our values and a hig ...
-
Senior Systems Engineer
2 days ago
ASTRION, INC. Bedford, United StatesOverview: · Senior Systems Engineer · Be the Difference · Astrion offers comprehensive services that boost preparedness, optimize performance, and ensure success across various domains, from Cyber to Digital, Mission and Systems, servicing our nation's Civilian, Defense and Sp ...
-
Aviation Systems Engineer
4 weeks ago
The MITRE Corporation Bedford, United StatesWhy choose between doing meaningful work and having a fulfilling life? At MITRE, you can have both. That's because MITRE people are committed to tackling our nation's toughest challenges-and we're committed to the long-term well-being of our employees. MITRE is different from mos ...
-
Aviation Systems Engineer
3 weeks ago
The MITRE Corporation Bedford, United StatesWhy choose between doing meaningful work and having a fulfilling life? At MITRE, you can have both. That's because MITRE people are committed to tackling our nation's toughest challengesand we're committed to the long-term well-being of our employees. MITRE is different from most ...
-
Systems Engineer
3 weeks ago
Abacus Technology Hanscom Air Force Base, United StatesOverview · Abacus Technology is seeking a Systems Engineer to provide technical support for the Command, Control, Communication, Intelligence and Networks (C3I&N) Directorate at Hanscom AFB. This is a full-time position. · Responsibilities · Perform work that applies a broad theo ...
-
Systems Engineer
4 weeks ago
Insight Global Hanscom Air Force Base, United StatesJob Description · An employer in the Lexington, MA area is looking for a Senior Systems Engineer to support/advise a government customer in forming an acquisition strategy when related to Systems Engineering services. Daily responsibilities will include: · * Conduct reviews on pr ...
Senior Quality Systems Engineer - Billerica, United States - Quanterix
Description
Quanterix is a company that is digitizing biomarker analysis with the goal of advancing the science of precision health.The company's ultra-sensitive detection solution, Simoa, has the potential to change the way in which healthcare is provided today by giving researchers the ability to closely examine the role of biomarkers in the continuum of health to disease.
Quanterix' technology is designed to enable much earlier disease detection, better prognosis and precise treatment methods to improve the quality of life and longevity of the population for generations to come.
The technology is currently being used for research applications in several therapeutic areas, including oncology, neurology, cardiology, inflammation and infectious disease.
We are looking for an experienced and highly motivatedSenior Quality Systems Engineer (QMS)
to join our Quality Assurance team. This individual will be responsible for supporting Product Quality needs within the Quality organization.
The role will work with multiple groups within the organization to support efforts to gather, analyze, prioritize and communicate various product quality information to maximize customer satisfaction.
These efforts will include addressing Six Sigma/Lean/Continuous Improvement related activities.What You'll Do:
Support development and maintenance of Quality Management System planning, policies, processes, procedures, and controls ensuring that performance and quality of Quanterix products and services conform to ISO 9001, ISO 13485 and other applicable regulatory agency guidelines to ensure customer satisfaction
Support ISO 9001, ISO 13485, IVDR, 21CFR820 and other activities for the development, implementation, monitoring, and improvement of Quanterix quality systems
Support audits of systems, processes, and products to ensure compliance with regulations and the Quality System including third party and customer audits
Support the feedback/complaint handling process through maintenance of complaint handling QMS requirements, processes, and procedures, including requirements for test plans, and investigation protocols as applicable
Analyze, trends and develop QA performance metrics reports
Coordinate/track/drive closure of QMS audit report responses, CAPAs, deviations, etc. to ensure closure and implementation in a timely manner
Support the Internal Audit Program by participating in internal audits, and supporting timely resolution of observations and nonconformities
Write and implement standard operating procedures and work instructions for QA functions
Develop QMS training and help foster a quality-oriented culture
What We'll Expect From You:
BS/BA degree in Biotechnology, Life Science, Engineering, or equivalent minimally, advanced degree is a plus (M.S. in a Life Science, or equivalent)
Professional certification is desired (i.e., Six Sigma, ASQ certifications, PMP)
5+ years related ISO 13485 Quality Assurance or Quality Systems experience
In-vitro diagnostic (reagents and instrumentation/software) experience preferred
Strong understanding of QSR and ISO regulatory requirements is required
Strong understanding and experience with Design Control requirements is required
Able to lead cross-functional teams and to work independently, without instruction
Highly organized and detail oriented
Strong work ethic and organizational skills to manage multiple projects under tight deadlines with a collaborative attitude is a must.
Like Working For Us:
Our Technology :
Quanterix' technology is designed to enable much earlier disease detection, better prognoses and enhanced treatment methods to improve the quality of life and longevity of the population for generations to come.
The technology is currently being used for research applications in several therapeutic areas. The company was established in 2007 and is in Billerica, Massachusetts. For additional Information, pleaseOur Commitment to Employees :
At Quanterix, we take pride in our employees' incredible work ethic, and we want to reward and recognize that by offering competitive compensation and a 401k plan with an employer match, as well as competitive health, dental, and vision benefits for employees and their dependents.
We also offer an unlimited vacation policy to all exempt employees, and a generous PTO policy for non-exempt employees.All employees are awarded Equity, and we have an Employee Stock Purchase Plan, a Performance Bonus, and 1:1 Financial Counseling/Planning.
We also offer Tuition Assistance. We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free snacks and drinks every dayQuanterix is committed to a Diverse and Inclusive workplace.
Quanterix is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.
Quanterix will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.#LI-JV1 #LI-Onsite
#J-18808-Ljbffr