Senior Quality Engineer

2 weeks ago

Jacksonville, United States Planet Pharma Full time

MUST HAVE:

  • Strong Risk Management Experience, Experience in Risk Documentation: Write, review, approve of Riks Management files, RPM calculations, Risk Mitigations etc.
  • Bachelors degree in Engineering Science or Technical field.
  • Minimum of 4 years of work in medical device industry experience in Engineering and Quality OR
  • Strong Experience in Validation/Qualification activities: Write, coordinate, execute, and create reports, IQ/OQ/PQ, MVPR, Sampling size determination: For Attribute or variable data, Strong statistical background etc
  • Able to work with minimum of supervision in a hybrid working organization set up bull Good writing and documentation skills.
  • Good organizational and verbal communication skills.
  • Ability to work in fast-track schedule and meet deliveries on time.
  • Ability to communicate effectively.
  • Ability to interact with a very diverse team keeping high ethics standards.
  • Demonstrate commitment with the company Core Values.

NICE TO HAVE:

  • ASQ Quality Engineer Certification.
  • Bilingual English/Spanish preferred but not required.
  • Previous Medical Device experience is helpful.
  • DMAIC Lean / Six Sigma Certification
  • Manufacturing experience within a controlled and regulated industry.


Years of Experience Required: Minimum 4 years.


Responsibilities may include the following and other duties may be assigned.

  • Day to day Risk Management review is anticipated. Strong Risk Management experience is a must.
  • Develop execute analyze and report on validations/qualifications activities including but not least: IQ OQ PQ MVP Test Method Validations to support commercial release product lines.
  • Evaluate review and/or update Risk Management files to be following ISO standards and local procedures.
  • Provides oversight for the development and maintenance of quality programs systems processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
  • Provides expertise and guidance in interpreting policies regulatory and/or governmental regulations and internal regulations to assure compliance.
  • Works directly with operating entities with multiple functions internal and external to provide quality engineering support to assure requirements meet project expectation and meet local procedures and regulations.
  • Prepares reports and/or necessary documentation in the project scope and provides to applicable stakeholders both internal and external on scheduled expected time.
  • Develops modifies applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
  • Implements methods and procedures for inspecting testing and evaluating the precision and accuracy of products and production equipment when require.
  • Specifies inspection and testing mechanisms and equipment conducts quality assurance tests and performs statistical analysis to products or materials to meet required standards and specifications.
  • Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
  • May specialize in the areas of design incoming material production control product evaluation and reliability inventory control and/or research and development as they apply to product or process quality.
  • Perform detailed Root Cause Investigation of failed product or processes using various quality tools 5 Whys 6 M Ishikawa Diagram Pareto Charts when require.
  • Interface with Production Manufacturing/Process Engineering RampD and Regulatory departments to resolve process issues and implement changes.
  • Apply knowledge of process control tools statistical sampling and other analytical techniques on the qualification activities to maximize the quality and flow of product through the production line.
  • Identify analyze and manage risk through product life cycle with use of risk management tools.

DIFFERENTIATING FACTORS

Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists may manage projects / processes.


Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives through building relationships and consensus to reach agreements on assignments.


Innovation and Complexity: Problems and issues faced are difficult and may require understanding of multiple issues job areas or specialties . Makes improvements of processes systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.


Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts statuses ideas and issues to achieve objective and influence decision making.


Leadership and Talent Management: May provide guidance coaching and training to other employees within job area. May manage projects requiring delegation of work and review of others' work product .


Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years relevant experience.

  • Senior Quality Development Engineer

    2 months ago

    Jacksonville, United States Pure Power Technologies Inc Full time

    Job DescriptionJob DescriptionSenior Quality Development EngineerStanadyne is known around the world as a leading supplier of diesel fuel systems and components. In addition, Stanadyne is quickly becoming an industry leader in the fast-growing field of Gasoline Direct Injection (GDI). Our products are for engine applications in agriculture, construction,...

  • Medical Device Senior Quality Engineer

    7 days ago

    Jacksonville, United States Grove Technical Resources, INC Full time

    Job Title - Medical Device Senior Quality Engineer Job Location - Jacksonville, Florida (Fully Onsite)Type: W2 contractMust Have: Strong Risk Management Experience (Experience in Risk Documentation: Write, review, approve of Riks Management files, RPM calculations, Risk Mitigations, etc.).(Write, coordinate, execute, create reports, IQ, OQ, PQ, MVPR,...

  • Medical Device Senior Quality Engineer

    1 week ago

    Jacksonville, United States Grove Technical Resources, INC Full time

    Job Title - Medical Device Senior Quality Engineer Job Location - Jacksonville, Florida (Fully Onsite)Type: W2 contractMust Have: Strong Risk Management Experience (Experience in Risk Documentation: Write, review, approve of Riks Management files, RPM calculations, Risk Mitigations, etc.).(Write, coordinate, execute, create reports, IQ, OQ, PQ, MVPR,...

  • Senior Quality Engineer

    3 months ago

    Jacksonville, United States Katalyst Healthcares & Life Sciences Full time

    Responsibilities: Day-to-day Risk Management review is anticipated. Strong Risk Management experience is a must. Develop, execute, analyze, and report on validations/qualifications activities including but not least: IQ, OQ, PQ, MVP, Test Method Validations to support commercial release product lines. Evaluate, review and/or update Risk Management files to...

  • Senior Quality Engineer

    1 month ago

    Jacksonville, Florida, United States Katalyst Healthcares & Life Sciences Full time

    Responsibilities:Day-to-day Risk Management review is anticipated. Strong Risk Management experience is a must. Develop, execute, analyze, and report on validations/qualifications activities including but not least: IQ, OQ, PQ, MVP, Test Method Validations to support commercial release product lines.Evaluate, review and/or update Risk Management files to...

  • Senior Manager, Quality Assurance

    1 month ago

    Jacksonville, Florida, United States KBR Full time

    Title:Senior Quality Assurance Manager at KBR's Marine Corps Prepositioning ProgramKBR's Marine Corps Prepositioning Program (MCPP) at Blount Island in Jacksonville, Florida is looking for a Senior Quality Assurance Manager to join their team.Directs the management, integration, and coordination of quality efforts for military tactical vehicles and ground...

  • Quality Engineer

    2 weeks ago

    Jacksonville, United States enVision Staffing Solutions Full time

    This is an exciting role for a Quality Engineer with strong Electrical Engineering fundamental skills. Our client is a Construction Technology Consultant managing projects at Data Center sites. They have partnered with a Power Infrastructure Consultancy company installing the power system at the Data Centre and are seeking site Program Managers and a Quality...

  • Quality Engineer

    2 weeks ago

    Jacksonville, United States enVision Staffing Solutions Full time

    This is an exciting role for a Quality Engineer with strong Electrical Engineering fundamental skills. Our client is a Construction Technology Consultant managing projects at Data Center sites. They have partnered with a Power Infrastructure Consultancy company installing the power system at the Data Centre and are seeking site Program Managers and a Quality...

  • Senior Software Engineer

    2 months ago

    Jacksonville, United States Tactical Air Support Full time

    Job DescriptionJob DescriptionTactical Air Support Inc.Senior Software EngineerJacksonville, FLStarting Salary $120,000+ DOEPosition SummaryTactical Air is currently seeking a Senior Software Engineer for designing, developing, and maintaining high-quality software solutions. As a Senior Software Engineer, you will own a significant portion of our product...

  • Senior Refrigeration Engineer

    3 hours ago

    Jacksonville, Florida, United States CRB Full time

    About the RoleWe are seeking a highly skilled Senior Refrigeration Engineer to join our team at CRB. As a key member of our engineering team, you will be responsible for overseeing the design and implementation of refrigeration systems for our clients in the life sciences and food and beverage industries.Key ResponsibilitiesProject Management: Plan and...

  • Head of MBP Quality Engineering

    2 months ago

    Jacksonville, Florida, United States FIS Global Full time

    Position Type : Full time Type Of Hire : Experienced (relevant combo of work and education) Travel Percentage : 5 - 10%Job DescriptionRole and ResponsibilitiesReporting to an SVP of Engineering, Modern Banking Platform (MBP), the Senior Director, Head of MBP Quality Engineering will play a critical role in driving innovation and growth for the Banking...

  • Senior Structural Engineer

    2 weeks ago

    Jacksonville, Florida, United States G.M. Hill Engineering Inc Full time

    Position Overview:The role of Senior Structural Engineer necessitates extensive expertise in structural design and engineering methodologies. You will be tasked with planning and executing independent projects that require discernment in the assessment, selection, application, and modification of engineering techniques, procedures, and standards.Key...

  • Senior Quality Automation Engineer

    7 days ago

    Jacksonville, Florida, United States Editech Staffing Full time

    Position Overview:As a Lead Automation Specialist, you will be instrumental in driving the evolution of our software solutions, collaborating with a team of skilled IT and business professionals. This full-time position offers the chance to spearhead automation projects, create effective testing frameworks, and uphold the highest quality benchmarks in our...

  • Quality Engineer

    3 months ago

    Jacksonville, United States The New IEM, Llc Full time

    Job DescriptionJob DescriptionIEM (Industrial Electric Mfg.), the titan of custom electrical distribution and power quality equipment in North America, stands as the pinnacle of innovation and service excellence. With a global reach, IEM crafts bespoke solutions to power the dynamic needs of thriving industries worldwide. Join us in this thrilling journey...

  • Sr. Quality Assurance Engineer

    3 months ago

    Jacksonville, United States SS&C Technologies Holdings Full time

    Job Description Senior Quality Assurance EngineerLocation(s): Jacksonville, FL - HybridGet To Know The TeamIn this role as Sr. Quality Assurance Engineer, you will be working on a fast-paced Agile team focused on building functionality to support our Managed Services team and expand our service offerings for hosted clients. This involves close collaboration...

  • Senior Estimation Engineer

    2 weeks ago

    Jacksonville, Florida, United States BB&E Full time

    Senior Cost EngineerBB&E is a prominent civil and environmental engineering firm, recognized for its contributions to both Federal and Industrial sectors across the nation. Our expertise lies in Environmental Consulting, Facilities Engineering, and Program/Project Management, catering to both governmental and private clients.Position OverviewWe are in search...

  • Senior Structural Engineering Leader

    2 weeks ago

    Jacksonville, Florida, United States Highlander Consultants Full time

    We are looking for a Senior Structural Engineering Leader to take charge of providing guidance and technical direction within a dynamic and award-winning firm.Comprehensive Job OverviewPOSITION SUMMARYWe are in search of a Principal Structural Engineer who will be responsible for delivering leadership, technical guidance, performance assessment, and ongoing...

  • Senior Structural Engineering Leader

    2 weeks ago

    Jacksonville, Florida, United States Highlander Consultants Full time

    We are looking for a Senior Structural Engineering Leader to provide direction and technical guidance within a dynamic and innovative organization.Comprehensive Job OverviewPOSITION SUMMARYWe are in search of a Principal Structural Engineer who will take charge of offering leadership, technical direction, performance evaluation, and ongoing enhancement of...

  • Supplier Quality Engineer

    2 months ago

    Jacksonville, United States Pure Power Technologies Inc Full time

    Job DescriptionJob DescriptionSupplier Quality EngineerStanadyne is known around the world as a leading supplier of diesel fuel systems and components. In addition, Stanadyne is quickly becoming an industry leader in the fast-growing field of Gasoline Direct Injection (GDI). Our products are for engine applications in agriculture, construction, power...

  • Senior Structural Engineer

    3 weeks ago

    Jacksonville, United States TRC Talent Solutions Full time

    TRC is currently seeking a Senior Structural Engineer (S.E.) for a full-time/direct-hire role for a client in the Jacksonville area.This position is responsible for managing all aspects of and phases of structural engineering design development practices in in adherence to U.S. Navy, Marine Corps, Air Force and Army surveying, planning and design standards....