Quality Assurance Engineer

2 months ago


Vista, United States DJO Global Full time

Job Description:

At Enovis we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence - with the goal of transforming medical technology as we know it.

Because that's how we change the lives of patients for the better. And that's how we create better together.

As a key member of the Quality team, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.

Job Title:

Quality Assurance Engineer

Reports To:

Manager, Quality Assurance

Location:

Vista, California - Onsite Monday - Friday

Business Unit Description:

Vista Manufacturing Center | Bracing & Support

Job Title/High Level Position Summary:

Under general direction, conducts the most technical and complex quality analysis and tests of a quality control program and recommends necessary quality procedure changes. Records and analyzes customer claims and prepares reports on rejected or defective products. Assists in the development of new methods and procedures. Trains junior and inter staff. Role typically requires more than 2 years of experience.

Key Responsibilities:

  • Preparation, implementation, and maintenance of Master Quality Plan.
  • Involvement in quality improvement facilitation by establishing methods of data collection, control charting, dimensional inspection, documentation, or other experimental design techniques.
  • Involvement on the Master Validation Plan (IQ, OQ, PQ) regarding validation and verification Processes
  • Responsible for continual improvement activities to enhance the quality system, such as 5S, Kaizen lean methods, etc.
  • Develop training to build quality awareness.
  • Lead quality resources to complete tasks associated with NPI, focused inspections and quality investigations.
  • Interface with Engineering and Operations to ensure transfer to Production of new products are in accordance with approved data.
  • Support the Quality Inspectors/Techs to ensure that products and processes comply with the relevant requirements of the quality management system.
  • Conduct audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions.
  • Analyze failure, corrective and preventive action to respond to customer complaints.
  • Create and maintain company quality documentation, such as quality manuals, quality procedures, etc.
  • Responsible for planning, organizing and managing the overall activities of receiving / outgoing quality functions.
  • Continuously improving QA receiving inspection process and procedures.
  • Ensure timely resolution of supplier failure, corrective actions and preventive actions.
  • Assists in developing a good working relationship with manufacturing and support their gate-measurement issues.
  • Assist in driving continuous improvements as necessary through the appropriate personnel.
  • Manage Nonconformance System and the COPQ Initiatives.
  • Manage the resolution of customer and internal quality concerns utilizing disciplined problem-solving techniques.
  • Work on DOE projects with project Teams
  • Facilitate and Manage Gage R&R, SPC and Capability requirements.
  • Participate on Launch and Current Production Engineering Changes
  • Support Lean Initiates
  • Daily review of Quality performance Scorecards.
  • Perform internal audits as per the audit schedule.
  • Assist other Quality Department functions as needed. (Cross-training)
  • Maintain reporting and disposal procedures for RMA scrap material.
  • Ensure a safe work environment is maintained, appropriate safety systems/processes are utilized, and insure compliance with all OSHA and other state/federal safety and environmental related rules and regulations.
  • Provide growth and development opportunities for associate engagement and satisfaction.
  • Maintain and comply with all other company and corporate systems and procedures as applicable for your area of responsibility.
  • Assist in and support Notified Body Audits, FDA inspections and other 3rd party audits.
  • Performs other duties as assigned by Management.
  • 70% of time is spent in a resource capacity. 30% of responsibilities are in leadership activities

Minimum Basic Qualifications:

To perform this job successfully, an individual must be able to perform essential duties satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required:

Education/Experience

  • A bachelor's degree in Engineering or other technical discipline degree is required (or equivalent years' experience).
  • A minimum of 2 years of experience in quality engineering or related field with application and implementation of (GMP/QSR/ISO/MDD and Canadian Medical Device) regulations a plus, with focus on, process validations, product development supports
  • Required knowledge of FDA/GMP, CMDR, MDD and ISO 13485 quality standards.
  • ASQ certification with active local membership is preferred.
  • Lean Six Sigma Green Belt or higher is also preferred.
  • Experience with Quality related tools (D and P FMEA, QFD, SPC, Risk Analysis, DOE, and TQM)
  • To perform this job successfully, an individual should have knowledge of Microsoft Word, or equivalent word processing software; Excel, or equivalent spreadsheet software. Statistical analysis and data base searches. Agile and Oracle experience highly desired.
  • Experience in the Medical Device Industry and lean manufacturing is a plus.
  • Must have statistical aptitude and understand concepts of geometric dimensioning and tolerance and knowledge of problem solving techniques.
  • Personal computer skills are required, as well as excellent verbal and written communication skills.

Certifications, Skills, Competencies

  • Expert working knowledge of US and International quality system regulations.
  • Proven project management skills; able to complete technical projects with minimal supervision. Strong interpersonal communication and teamwork skill.
  • Ability to understand and interpret drawings and data - GD&T knowledge to interp

"Creating better together". It's the Enovis purpose, and it's what drives us and empowers us every day on a global scale. We know that the power to create better - for our customers, our team members, and our shareholders - begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.

Watch this short video and discover what creating better together means to us at Enovis:

Our Enovis Purpose, Values and Behaviors on Vimeo

ABOUT ENOVIS

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. Visit www.enovis.com to learn more.

EQUAL EMPLOYMENT OPPORTUNITY:

Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria and without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees' beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.

ABOUT ENOVIS

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond.For more information about Enovis, please visit www.enovis.com.

EOE AA M/F/VET/Disability Statement

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.



  • Vista, California, United States DJO Global Full time

    Job DescriptionWe are looking for a highly skilled Supplier Quality Assurance Engineer to join our team in Vista, California. As a key member of the Quality Assurance team, you will play a vital role in ensuring compliance with regulatory requirements and maintaining high-quality standards.About the RoleThe successful candidate will be responsible for...


  • Vista, California, United States Enovis Full time

    Job Overview: Enovis is seeking a Quality Assurance Specialist to join our team in Vista, California. This role will play an integral part in driving the medical technology industry forward through transforming patient care and creating better patient outcomes.This position requires a bachelor's degree in Engineering or other technical discipline, as well as...


  • Vista, California, United States DJO Global Full time

    About the Role:As a Supplier Quality Engineer at Enovis Corporation, you will play a crucial part in driving the medical technology industry forward through transforming patient care and creating better patient outcomes. This role involves implementing and performing Supplier Quality Engineering activities at our company's manufacturing location, ensuring...


  • Vista, California, United States DJO Global Full time

    **Job Summary:**We are seeking a highly motivated Quality Assurance Manager to lead our quality team in Vista, California.As a key member of our organization, you will be responsible for developing and implementing quality control procedures to ensure compliance with regulatory requirements.The estimated salary for this position is $130,000 - $160,000 per...


  • Vista, California, United States Danaher Corporation Full time

    Overview:">At Danaher Corporation, we strive to advance the real-life impact of tomorrow's science and technology. As a leading manufacturer in cancer diagnostics, we're looking for a talented Senior Supplier Quality Engineer to join our team.


  • Vista, California, United States Enovis Full time

    Company OverviewWe are Enovis Corporation, a leading medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Our culture of continuous improvement, global talent, and innovation fuels active lifestyles in orthopedics and beyond.Salary$120,000 -...


  • Vista, California, United States Enovis Full time

    Quality Assurance EngineerEnovis is seeking a Quality Assurance Engineer to join our team. As a Quality Assurance Engineer, you will play an integral part in helping us drive the medical technology industry forward through transforming patient care and creating better patient outcomes.Duties and ResponsibilitiesThe successful candidate will conduct complex...


  • Chula Vista, California, United States Delphinus Engineering Full time

    Job DescriptionDelphinus Engineering is seeking a highly experienced Marine Quality Assurance Manager to oversee the quality and compliance of our marine engineering services in Chula Vista, CA. As a key member of our team, you will be responsible for developing and implementing quality control procedures, conducting regular audits and inspections, and...

  • Quality Assurance

    2 weeks ago


    Vista, United States Protec Arisawa Full time

    Job Description: As a Quality Assurance & Field Service Technician, you will be responsible for ensuring that products and services meet the established standards of quality. Your main tasks will include conducting inspections on assembled and manufactured products, identifying defects, working with production personnel to ensure process standards and...

  • Quality Assurance

    1 week ago


    Vista, United States Protec Arisawa America, Inc. Full time

    Job DescriptionJob DescriptionJob Description:As a Quality Assurance & Field Service Technician, you will be responsible for ensuring that products and services meet the established standards of quality. Your main tasks will include conducting inspections on assembled and manufactured products, identifying defects, working with production personnel to ensure...

  • Quality Assurance

    2 weeks ago


    Vista, United States Protec Arisawa Full time

    Job Description: As a Quality Assurance & Field Service Technician, you will be responsible for ensuring that products and services meet the established standards of quality. Your main tasks will include conducting inspections on assembled and manufactured products, identifying defects, working with production personnel to ensure process standards and...

  • Quality Assurance

    5 days ago


    Vista, United States Eastridge Full time

    Job DescriptionJob DescriptionAre you detail-oriented, organized, and passionate about maintaining high-quality standards? We are seeking a Quality Assurance/Quality Control Support professional to join our growing team at a leading pharmaceutical capsule manufacturing company in Vista, CA.What You'll Do:Perform routine inspections and quality checks of...


  • Chula Vista, California, United States United Software Group Full time

    **Job Title:** Senior Software Test EngineerAbout the Role:We are seeking a skilled Senior Software Test Engineer to join our team at United Software Group in Chula Vista, CA. As a key member of our software quality assurance team, you will play a crucial role in developing and implementing software test systems that meet our high standards.Key...


  • Vista, United States DJO Global Full time

    Job Description: At Enovis we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence - with the goal of transforming medical technology as we know it. Because that's how we change the lives of patients for the better. And that's how we create better together. As a key member of the...


  • Vista, United States DJO Global Full time

    Job Description: At Enovis we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence - with the goal of transforming medical technology as we know it. Because that's how we change the lives of patients for the better. And that's how we create better together. As a key member of the...


  • Vista, California, United States DJO Global Full time

    Job OverviewWe are seeking a highly skilled Quality Engineer for Medical Devices to join our team. In this role, you will be responsible for implementing and performing Supplier Quality Engineering activities at our manufacturing location. This includes providing a leadership quality role in the implementation of the Site Supplier Quality Assurance...


  • Vista, United States BIO FILM INC Full time

    Join Bio Film Inc, a leading manufacturer of personal lubricant and sexual wellness products. We are seeking a highly skilled Quality Assurance Specialist to oversee our laboratory operations and ensure the highest quality standards.We offer a competitive salary of $65,000 per year, plus benefits and a 4-day work week.About the JobOversee laboratory...


  • Vista, United States Western CNC Full time

    Job DescriptionJob DescriptionExperienced CNC Quality Control:We are a fast pace, large CNC machine shop looking for a Quality Assurance Manager25+ Fanuc controlled vertical mills16+ controlled horizontal mills10+ CNC lathes with Fanuc controls10+ Brother milling machines6+ Hass milling machines2 Swiss machinesResponsibilities:First article inspections of...


  • Vista, California, United States Eastridge Workforce Solutions Full time

    Company OverviewEastridge Workforce Solutions is a leading provider of workforce solutions, committed to delivering high-quality products that make a difference. We are seeking a skilled Quality Assurance/Quality Control Support professional to join our team in Vista, CA.


  • Vista, California, United States BIO FILM INC Full time

    Job OverviewBioFilm Inc is a leading manufacturer of Astroglide Personal Lubricant and other sexual wellness products, driven by a commitment to excellence and continuous innovation.We are seeking a skilled Quality Assurance Specialist to join our team, with a strong focus on ensuring the highest industry standards and regulatory requirements for our...