Senior Quality Systems Engineer

4 weeks ago

Waltham, United States Paragonix Technologies, Inc. Full time

Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted cold preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Our product portfolio spans cardiac, thoracic, and abdominal preservation devices to improve donor organ quality and extend donor organ transport time.

Position Overview: As a Senior Quality Systems Engineer, you will play a crucial role in ensuring the highest standards of quality throughout our organization. This position requires a strategic thinker with a deep understanding of quality management systems, change control processes, and a proven track record of implementing and maintaining robust quality processes.


Responsibilities

1.   Quality Management System (QMS) Leadership:

·        Lead the development, implementation, and maintenance of the company's QMS in accordance with relevant industry standards and regulations.

·        Analyzing quality data and generating reports to assess the performance of the quality management system and identify trends or areas for improvement.

2.   Change Control:

·        Implement, manage, and drive continuous improvement in change control processes to ensure that changes to products, processes, or systems are documented, reviewed, and approved in accordance with established procedures.

·        Collaborate with cross-functional teams to assess the impact of proposed changes and ensure compliance with regulatory requirements.

3.   Audits and Inspections:

·        Plan, coordinate, and conduct internal and external audits to assess compliance with QMS requirements.

·        Prepare for and support regulatory inspections, ensuring a state of readiness.

4.   Training and Development:

·        Provide training and guidance to employees on quality systems, change control procedures, and related processes.

·        Foster a culture of quality throughout the organization through education and awareness initiatives.

5.   Supplier Management:

·        Collaborate with cross-functional teams to evaluate and qualify new suppliers.

·        Manage the supplier audit process to assess and ensure the compliance of suppliers with established quality standards.

·        Establishing key performance indicators (KPIs) to measure supplier performance.

·        Maintaining accurate records of supplier assessments, approved supplier list, audits, and performance evaluations

6.   Documentation and Record Management:

·        Oversee the creation, review, and maintenance of quality documentation and records.

·        Ensure documentation complies with regulatory standards and internal requirements.

7.   CAPA

·        Manage the Corrective and Preventive Actions (CAPA) program for compliance to internal procedures, ensuring timely resolution of planned activities.

·        Collaborate with teams to investigate and resolve quality issues, implement corrective actions to prevent recurrence, and verify effectiveness of actions.

8.   Process Improvement:

·        Identify opportunities for continuous improvement in quality processes and lead initiatives to enhance efficiency and effectiveness.

·        Implement Lean and Six Sigma methodologies to streamline processes and reduce nonconformities.


Qualifications

·        Bachelor's degree in engineering or scientific discipline; Master's degree is a plus.

·        Minimum 3 years of experience in a quality systems role, with a focus on the medical device industry.

·        In-depth knowledge of relevant quality standards and regulations, including ISO 13485, ISO 9001, and 21 CFR 820.

·        Proven experience in leading and implementing QMS processes, change control initiatives, and CAPA programs in a regulated environment.

·        Strong familiarity with risk management methodologies and their integration into quality processes.

·        Experience in conducting internal and external audits, with a preference for those holding certifications as lead auditors.

·        Demonstrated success in collaborating with cross-functional teams to drive continuous improvement in quality systems and processes.

·        Exceptional analytical and problem-solving skills, with a keen attention to detail.

·        Excellent communication and interpersonal skills, with the ability to effectively convey complex quality concepts to diverse audiences.

·        Familiarity with statistical methods and tools for data analysis.

·        Ability to stay abreast of changes in industry regulations and standards, ensuring ongoing compliance.

·        Proven track record of successful supplier management, including the qualification and oversight of suppliers in a regulated environment.

·        Strong leadership skills with the ability to inspire and mentor a team focused on achieving and maintaining high-quality standards.

·        Preference will be given to candidates with certifications as Lead Auditors (e.g., ISO 13485 Lead Auditor, ASQ Certified Quality Auditor).

·        Excellent oral and written communication skills in English.

·        Able to travel domestically and internationally as required (

  • Senior Software Quality Engineer

    1 day ago

    Waltham, United States Vicarious Surgical Full time

    Job Description Job Description As a Senior Software Quality Engineer, you will be a subject matter expert of compliance related to the development lifecycle and maintenance processes of product software and software development tools and validation and maintenance of non-product software. You will be responsible for quality system support for software R&D...

  • Senior Software Quality Engineer

    2 weeks ago

    Waltham, Massachusetts, United States Vicarious Surgical Full time

    As a Senior Software Quality Engineer, you will be a subject matter expert of compliance related to the development lifecycle and maintenance processes of product software and software development tools and validation and maintenance of non-product software. You will be responsible for quality system support for software R&D projects; generation and/or...

  • Senior Software Quality Engineer

    2 weeks ago

    Waltham, United States Vicarious Surgical Full time

    Job DescriptionJob DescriptionAs a Senior Software Quality Engineer, you will be a subject matter expert of compliance related to the development lifecycle and maintenance processes of product software and software development tools and validation and maintenance of non-product software. You will be responsible for quality system support for software R&D...

  • Senior Systems Engineer

    4 weeks ago

    Waltham, United States Advantage Technical Full time

    Senior Systems Engineer Must have DOD or Robotics experience. The ideal candidate will have 3 - 5 years of experience and enjoy working in a fast-paced environment, participating in engineering teams designing, testing, integrating, and developing support of next-generation robotic systems for the U.S. Military.Desired Qualifications:Bachelor of Science...

  • Senior Systems Engineer

    4 weeks ago

    Waltham, United States Advantage Technical Full time

    Senior Systems Engineer Must have DOD or Robotics experience. The ideal candidate will have 3 - 5 years of experience and enjoy working in a fast-paced environment, participating in engineering teams designing, testing, integrating, and developing support of next-generation robotic systems for the U.S. Military.Desired Qualifications:Bachelor of Science...

  • Senior Systems Engineer

    4 weeks ago

    Waltham, United States Advantage Technical Full time

    Senior Systems Engineer Must have DOD or Robotics experience. The ideal candidate will have 3 - 5 years of experience and enjoy working in a fast-paced environment, participating in engineering teams designing, testing, integrating, and developing support of next-generation robotic systems for the U.S. Military.Desired Qualifications:Bachelor of Science...

  • Systems Engineer

    4 days ago

    Waltham, United States BlackTree Technical Group, Inc. Full time

    Job DescriptionJob DescriptionThe Systems Engineering group is a cross-functional team that is responsible for deliveringdetailed design material covering all aspects of the medical device platform under development.As a member of this team, you will work closely with engineers in various disciplines, as well asclinical development, and marketing to support...

  • Systems Engineer

    6 days ago

    Waltham, United States BlackTree Technical Group, Inc. Full time

    Job DescriptionJob DescriptionThe Systems Engineering group is a cross-functional team that is responsible for deliveringdetailed design material covering all aspects of the medical device platform under development.As a member of this team, you will work closely with engineers in various disciplines, as well asclinical development, and marketing to support...

  • Research Engineer

    1 week ago

    Waltham, United States A123 Systems Full time

    A123 Systems, LLC is in search of a Research Enginee r for our Waltham, MA location. A123 Systems, LLC is a leading developer and manufacturer of lithium-ion batteries and battery systems for the transportation and commercial markets. Applicable to a wide range of industries, A123 Systems’ products remove many traditional technology constraints to provide...

  • Senior Graphics Engineer

    3 weeks ago

    Waltham, Massachusetts, United States Krevera Full time

    Senior Graphics Engineer - Join Our Cutting-Edge AI Team Position: Senior Graphics Engineer Location: Waltham MA Company: Krevera Inc. Join Our Mission: At Krevera, we are at the forefront of AI technology, pushing the boundaries of machine learning and data synthesis. We are currently seeking a highly skilled Senior Graphics Engineer to join our dynamic...

  • Sr. Systems Engineer

    3 weeks ago

    Waltham, United States The Panther Group Full time

    This candidate must have a proven track record as a systems engineer working on DoD development programs or in the field of robotics.   This person may also support systems logistics and lifecycle management tasks as well as support various process improvement initiatives within the group.Duties may include: Use Model Base System Engineering (MBSE) and...

  • Senior Embedded Software Engineer

    1 week ago

    Waltham, United States Vicarious Surgical Full time

    Vicarious Surgical is hiring a Senior Embedded Software Engineer to join our team in Waltham, MA. As a Senior Embedded Software Engineer, you will contribute to the development of much of the firmware that runs our robotic device. You will work closely alongside software, controls, and electrical engineers to specify and design solutions to complex...

  • Senior Embedded Software Engineer

    4 weeks ago

    Waltham, United States Vicarious Surgical Full time

    Job DescriptionJob DescriptionVicarious Surgical is hiring a Senior Embedded Software Engineer to join our team in Waltham, MA. As a Senior Embedded Software Engineer, you will contribute to the development of much of the firmware that runs our robotic device. You will work closely alongside software, controls, and electrical engineers to specify and design...

  • Senior Mechanical Engineer

    3 weeks ago

    Waltham, Massachusetts, United States Boston Engineering Full time

    Company DescriptionBoston Engineering improves the way people work and live through innovative product design and novel engineering. Our teams of product designers and engineers for the Medical, Commercial, and Defense sectors. Experts in robotics, control systems, embedded systems, DFX, and digital transformation, we are ISO 9001 and ISO 13485 certified....

  • Quality Systems Specialist

    4 days ago

    Waltham, United States Ehub Global Inc Full time

    Title: Quality Systems Specialist 6-12 month contract Schedule: Mon-Fri (HYBRID onsite Tues-Thurs) KEY AREAS OF JOB ACCOUNTABILITY: (list of key objectives and quantifying standards) ·The Quality System Specialist, under the direction of the QS&C management team, will be responsible to support the global Quality Systems and their operations in ensuring...

  • Quality Systems Specialist

    2 days ago

    Waltham, United States GQR Full time

    Title: Quality Systems Specialist Status: Contract through end of year Location: Hybrid in Waltham, MA Hourly pay rate: $45 Hybrid- 3 days minimum will be onsite. Onsite Tuesday, Wednesday, and Thursday. KEY AREAS OF JOB ACCOUNTABILITY: The Quality System Specialist, under the direction of the QS&C management team, will be responsible to support the global...

  • Quality Systems Specialist

    3 days ago

    Waltham, United States GQR Full time

    Title: Quality Systems SpecialistStatus: Contract through end of yearLocation: Hybrid in Waltham, MAHourly pay rate: $45Hybrid- 3 days minimum will be onsite. Onsite Tuesday, Wednesday, and Thursday.KEY AREAS OF JOB ACCOUNTABILITY:The Quality System Specialist, under the direction of the QS&C management team, will be responsible to support the global Quality...

  • Quality Systems Specialist

    3 days ago

    Waltham, United States GQR Full time

    Title: Quality Systems SpecialistStatus: Contract through end of yearLocation: Hybrid in Waltham, MAHourly pay rate: $45Hybrid- 3 days minimum will be onsite. Onsite Tuesday, Wednesday, and Thursday.KEY AREAS OF JOB ACCOUNTABILITY:The Quality System Specialist, under the direction of the QS&C management team, will be responsible to support the global Quality...

  • Quality Systems Specialist

    4 days ago

    Waltham, United States GQR Full time

    Title: Quality Systems SpecialistStatus: Contract through end of yearLocation: Hybrid in Waltham, MAHourly pay rate: $45Hybrid- 3 days minimum will be onsite. Onsite Tuesday, Wednesday, and Thursday.KEY AREAS OF JOB ACCOUNTABILITY:The Quality System Specialist, under the direction of the QS&C management team, will be responsible to support the global Quality...

  • Quality Systems Specialist

    1 week ago

    Waltham, United States Ehub Global Inc Full time

    Title: Quality Systems Specialist6-12 month contractSchedule: Mon-Fri (HYBRID onsite Tues-Thurs)KEY AREAS OF JOB ACCOUNTABILITY:(list of key objectives and quantifying standards) ·The Quality System Specialist, under the direction of the QS&C management team, will be responsible to support the global Quality Systems and their operations in ensuring...