Medical Device Quality Engineer II - CAPA & Compliance
ConforMIS, Inc.
ConforMIS, Inc. is looking for a Product Quality Engineer II in Wilmington, MA. You will oversee quality assurance activities, drive process improvements, and collaborate across various teams to maintain compliance with regulatory standards. The ideal candidate should have a Bachelor’s degree in Engineering or Biomedical fields and at least 2 years of experience in the medical device sector. Proficiency in FDA guidelines and ISO standards is highly beneficial. The role requires strong communication skills, attention to detail, and the ability to thrive in a fast-paced, dynamic environment. #J-18808-Ljbffr ConforMIS, Inc.
$90k - $102k
Spectra Medical Devices, LLC in Wilmington, Massachusetts is seeking a Quality Engineer, Level II to ensure compliance with quality standards in medical device manufacturing. The ideal candidate will hold a Bachelor’s degree and have 2-4 years of experience in Quality...Suggested$66k - $88k
...DESCRIPTION How will you make an impact? As a Quality Engineer, II, you will be responsible for facilitating the Investigation and CAPA process to enable the site to reduce the... ..., which includes: A choice of national medical and dental plans, and a national vision...SuggestedTemporary workWork at office$92.6k - $139.6k
Software Quality Assurance Engineer II/III We are Textron Systems. Job Summary You will have the opportunity... ...with and mentor engineers to ensure compliance to Textron’s development process... ...plans that fit your lifestyle- 3 medical plans, prescription drug coverage, dental...SuggestedFull timeTemporary workCasual workWork at officeLocal areaRelocationFlexible hoursShift workDay shift$57 per hour
...Our client, a leading medical device organization, is... ...seeking a Senior Software Quality Assurance Engineer to join their team.... ...lifecycle, ensuring compliance with design controls... ...engineering (Class II/III preferred)... ...techniques Experience with CAPA, audits, and quality...SuggestedFull timeContract work- ...alternative application process. Product Quality Engineer II Active - Regular full-time Wilmington,... ...Corrective Action/Preventive Action (CAPA) program. Lead or assist with the... ...Quality Engineering experience in the medical device industry and/or experience in an FDA regulated...SuggestedFull timeWork at office
$92.6k - $176.2k
Textron in Wilmington, Massachusetts is seeking a Software Quality Assurance Engineer II/III to join its Weapon Systems division. This... ...software development lifecycle, mentoring engineers for compliance, and conducting quality oversight on testing and release...- A leading medical device manufacturer is seeking a Manufacturing Engineer II responsible for selecting and developing production processes for patient-tailored implants... ...The role requires optimization of processes and compliance with FDA QSR regulations. #J-18808-Ljbffr Page...
- Mass Digital Health is seeking a Design Quality Engineer in Bedford, MA. This role entails... ...transfer, ensuring quality and regulatory compliance. Key responsibilities include developing... ...quality improvement projects, and managing CAPA processes. The ideal candidate must...
- ...technology company in Cambridge, MA, is seeking a Quality Systems Engineer to manage quality processes and ensure compliance with FDA regulations. The successful... ...years’ experience in quality operations within medical device manufacturing and will be responsible for risk...Full time
$80k - $103k
...decades, Cirtec Medical has been a... ...complex medical devices. We specialize... ...solutions for Class II and III devices... ...auditing the quality of all manufactured... ...in support of engineering projects.... ...protocols to ensure compliance with the... ...manufacturing. CAPA (Corrective and...Work at office$90k - $102k
...our field. Elevaris Medical Devices is leveraging a legacy... ...are development and engineering experts focused on delivering... ...working as a Quality Engineer, preferably... ...providing Quality and Compliance related support to the... ...implementation of CAPA Aid in the implementation...Contract work$104k - $115.5k
...(USA) Job Summary Validation Engineer II is expected to execute validation... ...manufacturing systems in compliance with cGMP requirements, industry... ...in equipment/utility related CAPAs, Deviations, and... ...benefit programs which include medical, dental and vision coverage;...Work at officeFlexible hours$66k - $88k
SwiftCruit is seeking a quality assurance professional in Bedford, MA. The position requires... ...2+ years of experience in quality or engineering within a regulated industry.... ...benefits package is provided, including medical plans, retirement programs, and paid time...$135k - $160k
...is seeking a Senior Designs Assurance Quality Engineer located in Billerica, Massachusetts.... ...providing quality engineering support for medical device product families. Candidates should... ...with various teams to ensure compliance with quality standards and regulations...- ...What You'll Do The Quality Engineer will provide support for manufacturing... ...of Change Controls, CAPAs and Deviations. Support new... ...above programs to ensure compliance with regulatory requirements... ...related to the manufacturing of medical devices. What You Bring...Full timeImmediate start
- Medium is seeking a Controls Engineer II to enhance its manufacturing operations by designing, building, and scaling automation systems. The ideal candidate will have a background in industrial automation, with practical experience in Ignition SCADA and PLC programming....
$80k - $100k
A leading engineering solutions company is looking for a Mechanical Engineer II with 3-5 years of experience. This hybrid role involves designing and testing mechanical concepts while ensuring they meet client needs. Candidates should have a Bachelor's degree in mechanical...Flexible hours$160k - $190k
Overview Role Summary: The Regulatory Affairs Manager II leads the company’s post‑market regulatory program to ensure global compliance for commercialized IL-labeled medical devices and manages a team of regulatory professionals in this endeavor. This leadership role owns...Worldwide$80k - $100k
Our Mission Through inspired engineering and design, we deliver outstanding... ..., innovation, integrity, quality, and reliability, we want you... ...The Role Mechanical Engineer II - 3-5 years of relevant... ...Coverage: Access to comprehensive medical, dental, and vision insurance...Work at officeLocal areaFlexible hours- ...Validation Engineer II The Validation Engineer II performs... ...cleaning, sterilization, medical device, and drug product manufacturing... ..., and procedures are in compliance with current Good... ...provides validation input on quality systems such as CAPAs and change controls. The...Full timeImmediate start
$104k - $115.5k
...leading pharmaceutical company is seeking a Validation Engineer II to execute validation and qualification... ...involves supporting equipment validation, ensuring compliance with cGMP requirements, and participating in CAPAs and investigations. Candidates should have a bachelor...- Manufacturing Engineer II Department: MFG Engineering Reports To: Principal... ...objectives are the high quality, high volume production of... ...flow mapping. Assure compliance with the requirements set forth... ...support and development in the medical device industry. Previous...
$29 - $33 per hour
...CNC Machinist II is responsible... ...precision dental devices and components.... ...products meet strict quality, regulatory,... ...with engineering or maintenance... ...Quality & Regulatory Compliance • Adhere to... ...internal audits, CAPA activities, nonconformance... ...in dental, medical device, or...Full timeShift workAfternoon shift$77k - $86k
...Job Summary The Quality Assurance (QA) Specialist... ...supports the effectiveness, compliance, and continual... ...templates Prepare and review Engineering Change Orders (ECOs),... ...processes such as CAPA, nonconformance,... ...preferred Experience within medical device, IVD, pharmaceutical,...Work at officeLocal area- Cessna Aircraft Company, located in Wilmington, Massachusetts, seeks an ATE Software Engineer II responsible for developing Automated Test Equipment (ATE) for defense applications. The role demands expertise in Electrical Engineering and C# programming to design reusable...
- ...it meets the gold standard in toy quality. We're hiring a Quality Engineer to join our U.S. Product Safety team... ...product and packaging reviews for compliance with U.S. toy safety regulations. Apply... .... Assist the Quality Manager with CAPAs, internal audits, root cause...Full timeWork at office
£45k - £57k per year
...Kingdom Senior Product Quality Engineer Join a team where your... ...of life‑changing medical technology. As a Senior... ...will help ensure that devices used in healthcare settings... ..., and regulatory compliance. This role offers the... ...mitigations Support CAPA activities where required...Worldwide- Analog Devices, Inc. is seeking a Quality Systems Engineer in Wilmington, MA to develop and maintain quality management systems for medical devices. Responsibilities include supporting compliance with ISO 13485 and FDA regulations, coordinating training activities, and...
$90k - $130k
...Looking For Phoenix Tailings is looking for a hands‑on Production Engineer II with a background in Mechanical or Chemical Engineering to... ...30,000 total cash compensation plus equity. Healthcare: 100% Medical, dental, and vision coverage for employee Stock Options: Ownership...Night shiftRotating shift- Philips International is seeking a Software Test Engineer for their Bedford, MA location. In this role, you will validate software solutions in the cardiovascular diagnostic space to ensure they meet functional, safety, and performance standards. We're looking for a candidate...Full timeWork at office
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Medical Device Quality Engineer II - CAPA & Compliance. Be the first to apply!
- quality engineer Wilmington, MA
- quality systems engineer Wilmington, MA
- supplier quality engineer Wilmington, MA
- senior manager quality engineering Wilmington, MA
- program quality engineer Wilmington, MA
- customer quality engineer Wilmington, MA
- medical device Wilmington, MA
- rn quality Wilmington, MA
- quality distribution Wilmington, MA
- water quality Wilmington, MA

