Sr. Validation Engineer

2 weeks ago

Gainesville, United States Exactech Full time
DescriptionThe Sr Validation Engineer, QA provides cross-functional support in V&V development, planning and execution while maintaining corporate engineering and quality systems best practices, policies and procedures. The Sr Validation Engineer, QA is results oriented and has the knowledge and confidence in the areas of Quality Assurance and validation/verification (V&V).
Key Responsibilities
  • Provide focused, technical, hands-on engineering assistance regarding V&V requirements of medical device processes, materials, equipment and methods including project management, process design, document generation (IQ, OQ, PQ, SOPs, WIs and ETSs), critical process parameter development, protocol execution and summary reports.
  • Executes activities related to the compliance of the sterility assurance program (e.g. Biocompatibility/Endotoxin testing and quarterly dose audits).
  • Participates in the development and execution of robust inspection and test methods for V&V feasibility and qualification projects and stand alone studies.
  • Leads or participates in the validation of corporate software packages ensuring adherence to industry requirements.
  • Use statistical techniques, as necessary, to properly design and execute V&V activities.
  • Prepare documentation and execute V&V activities utilizing a risk based approach (pFMEA, FMEA, etc.) and Good Engineering Practices (GEPs) ensuring compliance to medical device industry regulations.
  • Coordinate personnel training, protocol and process documentation/record retrieval, as necessary, supporting timely execution and closure of all corporate V&V activities.  
  • Maintain corporate validation process auditing program ensuring timely completion of auditing activities.
  • Maintain V&V planning (Validation Project Dashboard) documenting progress towards completion of corporate V&V initiatives in preparation for monthly update meetings.
  • Lead the identification, maintenance, development and enhancement of corporate systems, processes and standards.
  • Identify, analyze and correct internal and external manufacturing deviations and/or anomalies related to V&V activities ensuring optimization of production processes.
  • Successfully contribute to cross-functional project teams in all areas of device cleanliness and manufacturing V&V work such as material testing, specification development, process capability studies, research, and investigation and process/test documentation.
  • Identify and communicate significant quality and compliance concerns to the Mgr. Validations, QA and associated project team leaders early in the V&V development phase.
  • Informs Regulatory Affairs of validation projects that may require further reporting/scrutiny (e.g. PMA devices).
  • Participate in the review and qualification of external supply chain V&V activities.
  • Take primary responsibility for company-wide validation related Corrective and Preventive Actions that may result from internal/external non-conformances, recalls and/or field actions.
  • Define and lead third party, customer and regulatory audits as they pertain to validations.

Skills Knowledge and ExpertiseEducation:
  • Bachelor’s Degree from an accredited institution required; Master’s Degree preferred 
 Experience:
  • Minimum 7 years experience in the medical device industry
  • Advanced level of technical software proficiency
  • Excellent Quality System knowledge required
  • Strong time management and project management skills are necessary.
  • Experience writing IQ/OQ/PQ V&V protocols.
  • Working knowledge of principles, concepts and practices of process V&V activities, Risk Management, FDA and ISO Regulations. 
  • General understanding of sterilization and related analytical testing is a plus.
    Must be able to work independently and in a team environment. 
Functional/Technical Knowledge, Skills and Abilities Required:
  • Statistical expertise in areas such as process capability, process assurance and sampling
  • Expertise in Microsoft Office products
  • Ability to work effectively in a team environment
  • ASQ Certifications preferred
  • Advanced level of technical software proficiency
  • Working knowledge of statistical analysis and sampling plans.
  • Excellent communication (written and verbal) skills.
  • Excellent organization skills.
About ExactechExactech is a global medical device company that develops and markets orthopaedic implant devices, related surgical instruments and the Active Intelligence® platform of smart technologies to hospitals and physicians. Headquartered in Gainesville, Fla., Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Visit www.exac.com for more information and connect with us on LinkedIn, VuMedi, YouTube, Twitter and Instagram.

  • Sr. Validation Engineer

    4 weeks ago

    Gainesville, United States Exactech Full time

    Sr. Validation EngineerDepartment: Manufacturing Engineering Employment Type: Full Time Location: Gainesville, FL Reporting To: Norbert Nasi Description The Sr Validation Engineer, QA provides cross-functional support in V&V development, planning and execution while maintaining corporate engineering and quality systems best practices, policies and...

  • Sr. Validation Engineer

    2 months ago

    Gainesville, United States Exactech Full time

    Job DescriptionJob DescriptionDescriptionThe Sr Validation Engineer, QA provides cross-functional support in V&V development, planning and execution while maintaining corporate engineering and quality systems best practices, policies and procedures. The Sr Validation Engineer, QA is results oriented and has the knowledge and confidence in the areas of...

  • Sr. Development Engineer Packaging

    4 weeks ago

    Gainesville, United States Exactech Full time

    Sr. Development Engineer PackagingDepartment: Manufacturing Engineering Employment Type: Full Time Location: Gainesville, FL Reporting To: Manager Packaging & End of Line Engineering Description Design and development of medical device packaging or sterilization cases. Includes qualification/testing of packaging configurations and process validation. Key...

  • Sr. Development Engineer Packaging

    1 month ago

    Gainesville, United States Exactech Full time

    Job DescriptionJob DescriptionDescriptionDesign and development of medical device packaging or sterilization cases. Includes qualification/testing of packaging configurations and process validation.Key ResponsibilitiesWith direction, design and develop package or sterilization case components for new or existing products.Define the design input requirements...

  • Sr. Supplier Development Engineer

    3 months ago

    Gainesville, United States Fox Factory Full time

    Position Summary:Coordinate development activities across multiple suppliers. Coordinate, validate, and analyze all Supplier Launch PPAP documentation. Troubleshoot supplier quality issues. Work with suppliers to drive cost reduction and quality improvement efforts. Position Responsibilities:Coordinate with project team in US to ensure suppliers meet...

  • Sr. Supplier Development Engineer

    3 months ago

    Gainesville, United States Fox Factory Full time

    Position Summary:Coordinate development activities across multiple suppliers. Coordinate, validate, and analyze all Supplier Launch PPAP documentation. Troubleshoot supplier quality issues. Work with suppliers to drive cost reduction and quality improvement efforts. Position Responsibilities:Coordinate with project team in US to ensure suppliers meet...

  • Sr. Clinical Specialist

    3 months ago

    Gainesville, United States Abbott Full time

    The Opportunity In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. What You’ll Work On Working under general direction, provides advanced engineering, sales,...

  • Sr. Technical Services Rep

    3 months ago

    Gainesville, United States Vector Security, Inc. Full time

    Job DescriptionJob DescriptionAt Vector Security We Think Big, Do the Right Thing, and Make a Difference Every Day! If this is how you like to work, we’d like to invite you to join our team as a Sr. Technical Services Representative!We offer great benefits, a competitive salary, and growth opportunities. We think you’ll find what you want here because...

  • Senior Systems Engineer

    3 days ago

    Gainesville, Texas, United States Safran Full time

    Job Description**Job Summary:**We are seeking a highly skilled Senior Systems Engineer to join our team at Safran Seats. As a key member of our engineering team, you will be responsible for managing product requirements, specifications, and compliance throughout the product development cycle.Main Responsibilities:Manage engineering projects, ensuring...

  • Systems Engineer II

    4 days ago

    Gainesville, United States Safran Full time

    Powered by Team Work, Safran Seats is a global leader in passenger and technical aircraft seating. With over one million seats in the fleets of major airlines, we offer innovative and high-value solutions for passengers, crews, and helicopters. Our comprehensive range includes seats from economy to first class, as well as specialized designs for pilots and...

  • Systems Engineer II

    7 days ago

    Gainesville, United States Safran Full time

    Powered by Team Work, Safran Seats is a global leader in passenger and technical aircraft seating. With over one million seats in the fleets of major airlines, we offer innovative and high-value solutions for passengers, crews, and helicopters. Our comprehensive range includes seats from economy to first class, as well as specialized designs for pilots and...

  • Upstream Process Development Engineer

    6 days ago

    Gainesville, Florida, United States Ascend Advanced Therapies Full time

    Job SummaryWe are seeking a highly skilled Senior Process Development and Manufacturing Engineer to join our team at Ascend Advanced Therapies. As a key member of our Process Development and Manufacturing department, you will be responsible for leading the development and optimization of upstream process unit operations for the production of gene...

  • Senior Systems Engineer

    1 day ago

    Gainesville, Texas, United States Safran Full time

    Job SummarySafran Seats is seeking a highly skilled Senior Systems Engineer to join our team in Gainesville, Texas. As a key member of our engineering team, you will be responsible for managing product requirements, specifications, and compliance throughout the product development cycle.Key ResponsibilitiesManage product requirements and specifications to...

  • Senior Engineering Manager

    3 days ago

    Gainesville, Florida, United States City of Gainesville Full time

    Job SummaryWe are seeking a highly skilled and experienced Senior Engineering Manager to join our team at the City of Gainesville. As a key member of our engineering department, you will be responsible for coordinating and supervising teams of engineers and utility designers to plan, develop, and implement large and complex projects.Key...

  • Senior Engineering Manager

    1 week ago

    Gainesville, Florida, United States City of Gainesville Full time

    Job SummaryWe are seeking a highly skilled and experienced Senior Engineering Manager to join our team at the City of Gainesville. As a key member of our engineering department, you will be responsible for coordinating and supervising teams of engineers and technicians in planning, developing, and implementing large-scale engineering projects.Key...

  • Principal Engineer and Utility Designer

    7 hours ago

    Gainesville, United States Gainesville’s City Commission Full time

    If you are an Internal City Employee, Retiree or Dependent/Survivor of a City Employee please apply internally via Career Icon in your Workday account. Make a difference in the community you live in! As a Community Builder—an employee with the City of Gainesville—you will have a direct hand in building and improving your community and making a visible...

  • Dynamic FEA Engineer I

    3 weeks ago

    Gainesville, United States Safran Seats Full time

    Job Description As a member of the Safran Seats business, you play a major role in teamwork that provides over one million seats to major airlines worldwide. Our commitment to superior quality, comfort and innovation ensure that you can take pride in doing meaningful work that supports the needs of passengers and crews alike. No matter your role, you...

  • Dynamic FEA Engineer I

    2 weeks ago

    Gainesville, United States Safran Seats Full time

    Job Description As a member of the Safran Seats business, you play a major role in teamwork that provides over one million seats to major airlines worldwide. Our commitment to superior quality, comfort and innovation ensure that you can take pride in doing meaningful work that supports the needs of passengers and crews alike. No matter your role, you...

  • Battery Systems Engineer

    2 weeks ago

    Gainesville, Georgia, United States Element Materials Technology Full time

    Battery Systems EngineerJob OverviewElement Materials Technology is seeking a Battery Systems Engineer to enhance our dynamic team. This role is pivotal in our focus on battery safety, performance evaluation, and failure analysis across various sectors, including automotive, aerospace, consumer electronics, and medical devices.As a vital member of our...

  • Traffic Operations Engineering Supervisor and Project Leader

    2 weeks ago

    Gainesville, Florida, United States City of Gainesville Full time

    If you are an Internal City Employee, Retiree or Dependent/Survivor of a City Employee please apply internally via Career Icon in your Workday account. Join us in making a significant impact in your community! As a Community Builder with the City of Gainesville, you will play a vital role in enhancing the quality of life for residents and contributing to the...