We have other current jobs related to this field that you can find below

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    1 month ago

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  • Quality Systems Engineer

    6 days ago

    Manchester, Iowa, United States XL Specialized Trailers Full time

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  • Quality Systems Engineer

    3 weeks ago

    Manchester, United States DEKA Research & Development Full time

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  • Quality Systems Engineer

    1 month ago

    Manchester, United States DEKA Research & Development Full time

    Job DescriptionJob DescriptionJoin our dynamic team at DEKA and be at the forefront of driving quality excellence! As our Quality Systems Engineer, you'll be a key player in our collaborative environment, working hand-in-hand with cross-functional teams to ensure the highest standards of quality and compliance.As a Quality Systems Engineer, you will...

  • Food Safety and Quality Assurance Manager

    2 days ago

    Manchester, New Hampshire, United States Gpac Full time

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    2 months ago

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    Manchester, New Hampshire, United States Flex Full time

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  • Quality Engineer

    3 months ago

    Manchester, United States XL Specialized Trailers Full time

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    Manchester, United States CareGivers Management Company LLC Full time

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  • Quality Engineer

    3 months ago

    Manchester, United States XL Specialized Trailers Full time

    Country: United States of America Location: XL Specialized Trailers, 1086 South 3rd St., Manchester, Iowa 52057 Position Overview: The XL Quality organization is looking for talented candidates to fill a new opening for a Quality Engineer on our QA & Continuous Improvement team. This role will serve as a subject matter experts (SME's) to lead the...

  • Quality Engineer

    3 months ago

    Manchester, United States XL Specialized Trailers Full time

    Job DescriptionJob DescriptionCountry:United States of AmericaLocation:XL Specialized Trailers, 1086 South 3rd St., Manchester, Iowa 52057Position Overview:The XL Quality organization is looking for talented candidates to fill a new opening for a Quality Engineer on our QA & Continuous Improvement team. This role will serve as a subject matter experts...

  • Plant Manager

    3 weeks ago

    Manchester, United States EG Professional Full time

    Job DescriptionJob DescriptionA great company in Manchester, CT is adding a Plant Manager to their team! This company offers great benefits that start the first day of employment and competitive salary. The Plant Manager is responsible for ensuring all company policies and procedures are followed and implementing, controlling all manufacturing systems to...

  • Quality Assurance Engineer

    14 hours ago

    Manchester, Iowa, United States XL Specialized Trailers Full time

    Company:XL Specialized TrailersPosition:Quality EngineerThe Quality team at XL Specialized Trailers is looking for talented individuals to fill the role of Quality Engineer within our QA & Continuous Improvement division. In this pivotal position, you will spearhead the execution and refinement of essential processes such as ISO-9001. You will also serve as...

  • Quality Control Specialist

    17 hours ago

    Manchester, Iowa, United States XL Specialized Trailers Full time

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    6 days ago

    Manchester, Iowa, United States XL Specialized Trailers Full time

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  • Plant Manager

    3 weeks ago

    Manchester, United States EG Workforce Solutions Full time

    A great company in Manchester, CT is adding a Plant Manager to their team! This company offers great benefits that start the first day of employment and competitive salary.The Plant Manager is responsible for ensuring all company policies and procedures are followed and implementing, controlling all manufacturing systems to include customer orders,...

  • Plant Manager

    3 weeks ago

    Manchester, United States EG Workforce Solutions Full time

    A great company in Manchester, CT is adding a Plant Manager to their team! This company offers great benefits that start the first day of employment and competitive salary.The Plant Manager is responsible for ensuring all company policies and procedures are followed and implementing, controlling all manufacturing systems to include customer orders,...

  • Quality Assurance Engineer

    6 days ago

    Manchester, Iowa, United States XL Specialized Trailers Full time

    Position Overview:The XL Specialized Trailers Quality team is in search of qualified candidates for the position of Quality Assurance Engineer. This role is essential in spearheading the execution and improvement of key quality initiatives, including ISO-9001 standards, throughout the organization. As a recognized authority in the field, the Quality...

Manager, Quality Management System

2 months ago

Manchester, United States Sequel Med Tech, LLC. Full time

About Sequel Sequel Med Tech is an early-stage company developing the next generation of precision drug delivery devices.

Job Overview The Manager of QMS will be a key member of our growing Quality/Regulatory team as we build out a robust QMS compliant with FDA and EU regulations. The Manager of QMS will first contribute to quality plans, training, document and record control system implementation, and Quality Management System items such as the Quality Manual, Quality Cross System reference, and Management Review. This role will also contribute to all areas of QA and Regulatory activities as Sequel builds out systems, and external manufacturing development.

Job Responsibilities and Essential Duties

Responsible for lifecycle management of policies and procedures in the GxP Quality Management System (QMS) Framework, including providing support with document authoring, approval, issuance, training, implementation, periodic review, and retirement. Responsible for document management for GxP records generated internally and externally. Contribute and support ongoing improvement efforts within quality systems and maintain quality systems to ensure compliance with applicable local and global regulations while meeting Sequel’s business requirements. Provide support during health authority inspections, internal audits, and other external audits. Develop, implement, and maintain a comprehensive quality management system (QMS) in accordance with relevant regulations (e.g., ISO 13485, FDA CFR 820) Review documents for accuracy, completeness, and compliance in accordance with relevant regulations (e.g., ISO 13485, FDA CFR 820). Develop and maintain documentation templates within the QMS and project databases and maintain hard copy records when required. Maintain site compliance with good documentation practices and cGxP data integrity requirements. Partners with functional areas to conduct periodic reviews of existing procedures and development of new and revised procedures. Serve as system administrator for account creation, password reset, signing authority management, approval routing workflows, user permissions, and general troubleshooting for Sequel’s quality management and documentation systems. Provide end-user onboarding and ongoing training for all program and project management systems for all staff and stakeholders. Establish key performance indicators (KPIs) and departmental metrics to monitor and improve quality across all functions. Responsible for tracking batch records, logbooks, and other controlled forms/documents. Drive and facilitate change management. Manage and train a team of quality professionals. Collaborate with other departments to ensure quality is integrated throughout the product lifecycle, addressing quality-related issues and implementing solutions. Foster a collaborative and inclusive team culture of quality professionals that values diversity and promotes innovation, and develops succession plans, skills assessments, and training. Minimum Requirements

Bachelor’s degree in technical field, or equivalent experience. 5+ years of experience working in a quality function within a medical device company (preferred), pharmaceutical or biotech company. Experience leading a team (preferred). Required Knowledge, Skills, and Abilities

Strong knowledge of Quality Management or Quality Engineering Principles and methodologies. Excellent problem-solving and analytical skills. Strong project and team leadership skills. Excellent communication skills (both verbal and non-verbal). Must be able to quickly and concisely summarize complicated technical topics. Quality certifications a plus: ASQ, CQE, CQM. Ability to exercise professional judgment in identifying organizational improvement. Ability to effectively work with cross-functional teams as a change agent, facilitator, coach, and mentor. Ability to travel nationwide and internationally, up to 10%.

Sequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Environmental/Safety/Physical Work Conditions

Ensures environmental consciousness and safe practices are exhibited in decisions Use of computer and telephone equipment and other related office accessories/devices to complete assignments May work extended hours during peak business cycles Physical requirements such as lifting specific weights

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