-
Quality Engineer
1 week ago
Katalyst Healthcares and Life Sciences Boston, United StatesResponsibilities: minimum of Technical/Engineering Degree with 5+ years of related experience Medical Device Supplier Quality domain? · Working knowledge of regulatory compliance requirements (i.e. Quality System Regulations (QSRs), · Medical Device Directive (MDD), ISO 9001, I ...
-
Quality Engineer
3 weeks ago
Connect Life Science Boston, United StatesPosition: Quality Engineer · Location: Boston Hybrid (25% onsite) · Duration: 6 Months Contract · A medical device contract manufacturer, bringing a device to the market are seeking a Quality Engineer who is a critical thinker, data driven, and quality minded. · Job Responsi ...
-
Quality Engineer
3 weeks ago
TetraScience Boston, United States[Full Time] Quality Engineer at TetraScience (United States) | BEAMSTART Jobs · Quality Engineer · TetraScience United States · Date Posted · 25 Jun, 2022 · Work Location · Boston, United States · Salary Offered · Not Specified · Job Type · Full Time · Experience Required · 3+ ...
-
Quality Engineer
3 weeks ago
Connect Life Science Boston, United StatesPosition: Quality Engineer · Location: Boston – Hybrid (25% onsite) · Duration: 6 Months Contract · A medical device contract manufacturer, bringing a device to the market are seeking a Quality Engineer who is a critical thinker, data driven, and quality minded. · Job Responsib ...
-
Quality Engineer
3 weeks ago
Pirouette Medical LLC Boston, United States[Full Time] Quality Engineer at Pirouette Medical (United States) | BEAMSTART Jobs · Quality Engineer · Pirouette Medical United States · Date Posted · 04 Mar, 2023 · Work Location · Boston, United States · Salary Offered · $60000 — $80000 yearly · Job Type · Full Time · Experi ...
-
Quality Engineer
1 week ago
Katalyst HealthCares & Life Sciences Boston, United StatesResponsibilities: A minimum of Technical/Engineering Degree with 5+ years of related experience Medical Device Supplier Quality domain? · Working knowledge of regulatory compliance requirements (i.e. Quality System Regulations (QSRs), · Medical Device Directive (MDD), ISO 9001 ...
-
Quality Engineer
3 days ago
Skanska Boston, United StatesSkanska is searching for a dynamic Quality Engineer. This is a great opportunity to start a career with a company that builds things that matter and values its team. We are proud to share our culture of diversity and inclusion. · Our work makes a clear contribution to society and ...
-
Quality Engineer
3 weeks ago
Myomo Inc Boston, United StatesThe Quality Engineer provides support to the QC Engineering Manager and team. The core aspects of this role are to focus on non-conforming materials, establish effective inspection methods, resolve supplier quality issues, and collaborate with Product Development to deliver effec ...
-
Quality Engineer
4 days ago
Skanska Boston, United StatesSkanska is searching for a dynamic Quality Engineer. This is a great opportunity to start a career with a company that builds things that matter and values its team. We are proud to share our culture of diversity and inclusion. · Our work makes a clear contribution to society and ...
-
Quality Engineer
3 weeks ago
Katalyst Healthcares and Life Sciences Boston, United StatesResponsibilities: Develop and implement quality management systems compliant with relevant regulatory standards (ISO 13485, FDA QSR, etc.) Conduct internal audits and inspections of all aspects of the quality system, including design, manufacturing, and distribution. Investigate ...
-
Quality Engineer
3 days ago
Katalyst Healthcares and Life Sciences Boston, United StatesResponsibilities: SME for Change Control Activities · Manage risk assessment and ensure appropriate actions are taken and documented in the QMS · Technical resource for NPI and tech transfer activities from a quality perspective · Manage equipment and facility suppliers for re ...
-
Senior Quality Engineer
3 weeks ago
Lumicity Boston, United StatesDirect message the job poster from Lumicity · Recruitment Consultant at Lumicity | Life Sciences | Senior and Executive Positions · My client is driven by a singular purpose: to transform the landscape of healthcare through groundbreaking innovations in medical device diagnostic ...
-
Supplier Quality Engineer
3 weeks ago
Connected Systems Partners Boston, United StatesJob Description · Job Description · Job Location: Peabody MA area · This Supplier Quality Engineer will assist in the supplier quality focused production goals of high volume electronics manufacturing. The hired individual will also focus on Process Engineering focused Manufact ...
-
Supplier Quality Engineer
3 weeks ago
INTELLECTT INC Boston, United StatesJob Title: · Supplier Quality Engineer · Location: · MA · Key Responsibilities: · Quality Standards: This role requires you to establish and maintain supplier quality standards, ensuring they align with industry regulations and the company's internal requirements. This could i ...
-
Director, Quality Engineering
3 weeks ago
Seismic Boston, United StatesPlease be aware we have noticed an increase in hiring scams potentially targeting Seismic candidates. Read our full statement on our Career's page. · Seismic, a rapidly growing Forbes Cloud 100 company, is the global leader in enablement, helping make sales teams better by becom ...
-
Software Quality Engineer
2 weeks ago
Money Fit by DRS Boston, United StatesSoftware Quality Engineer · Job Description · BrioHealth Solutions Inc., Inc. is seeking a Software Quality Engineer to support design quality efforts for an active implantable medical device, covering both clinical and commercial needs in a GMP environment. In this role, you w ...
-
Quality Engineer I
8 hours ago
Elemental Machines Boston, United StatesElemental Machines is looking for a full-time Quality Engineer to join our Ops team in the development of industry-leading IoT devices and sensors. In this position, you will take an active role in supporting the tactical processes used by EM to ensure our development and product ...
-
Senior Quality Engineer
3 days ago
Veeva Systems Boston, United StatesVeeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth pot ...
-
Senior Quality Engineer
3 weeks ago
Veeva Systems Boston, United StatesVeeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth pot ...
-
Engineer II, Quality
4 weeks ago
Integra LifeSciences Boston, United StatesChanging lives. Building Careers. · Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's pos ...
Lead Quality Engineer - Boston, United States - OPT Industries
Description
Company Description :
OPT Industries ) is a rapidly growing, venture-backed MIT spinoff company that focuses on building the next generation of additive manufacturing technology.
Working at the intersection of automation engineering, computational design, and polymer science, we design and commercially manufacture highly customizable materials and products- everything from medical devices to luxury fashion.
Lead Quality EngineerRole :
Multifaceted, hands-on technical Quality Engineering role responsible for leading OPT Industries Quality efforts with regards to design quality, manufacturing quality insurance, and quality system (QMS) development and management.
20% Design quality
20% Transfer to Manufacturing/Validation Support
20% QMS Development/Management (eQMS)
Principal Responsibilities :
Provide technical support and guidance from a Quality perspective throughout the new product development and transfer to manufacturing process.
Develop quality control plans, monitor and analyze quality performance, investigate production issues.
Use data and statistical analysis to support effective quality assurance and drive manufacturing improvements.
Provide technical quality leadership to project teams for project decisions and deliverables (Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, Process Validation).
Creation and review of Risk Management documentation such as Design Failure Mode and Effects Analysis (DFMEA).Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e. 5 Whys analysis, DMAIC problem solving methodologies).
Lead the organization in deploying a Quality Management System that complies with ISO 9001. Support documentation and compliance cross functionally, owning our eQMS system.
Write/review manufacturing, quality, engineering SOPs, FMEAs, and validations (MVP, CSV, IQ, OQ, PQ) to ensure conformance with regulations, as well as customer and business needs.
Develop test methods, inspection, and sampling plans for manufacturing in-process inspections along with raw material incoming inspection specifications.Apply sound engineering analysis and judgment to reduce the need for inspection at final, in-process, and incoming inspection to drive quality at the source.
Qualifications :5+ years of technical engineering experience in manufacturing and quality management.
5+ years of hands-on experience with the validation/qualification of new products, equipment, and processes.
Bachelor's degree in an engineering discipline.
Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues.
Experience leading process improvement projects using Six Sigma or Lean methodologies.
Experience implementing and/or sustaining a Quality Management System
Benefits :
OPT Industries provides the following benefits to all full-time employees: Medical, Dental, STD, LTD, Life and AD&D Insurance, Tax Free Commuter Benefits, 401k, and more.
OPT Industries is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
