Full-Time

Quality Assurance Engineer

Confirmed live in the last 24 hours

ENOVIS

ENOVIS

1,001-5,000 employees

Develops orthopedic and reconstructive medical devices

No salary listed

Mid, Senior

No H1B Sponsorship

Oceanside, CA, USA

Onsite Monday - Friday.

Category
QA & Testing
Quality Assurance
Requirements
  • 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.
  • 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.
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.
Desired Qualifications
  • 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)
  • Agile and Oracle experience highly desired.
  • Experience in the Medical Device Industry and lean manufacturing is a plus.

Enovis develops medical technology solutions aimed at improving patient outcomes and restoring mobility. The company has two main segments: Prevention & Recovery, which offers orthopedic solutions like bracing products and therapy systems for rehabilitation and sports medicine; and Reconstructive, which focuses on implant products for various joints and minimally invasive surgical tools. Enovis's products, including well-known brands like DonJoy and Aircast, are designed to address needs in pain management and recovery. What sets Enovis apart from competitors is its commitment to continuous improvement through the Enovis Growth Excellence (EGX) system, which enhances operations and customer satisfaction. The company's goal is to innovate in the medical technology field to create better outcomes for patients and healthcare providers globally.

Company Size

1,001-5,000

Company Stage

IPO

Headquarters

Wilmington, Delaware

Founded

2022

Simplify Jobs

Simplify's Take

What believers are saying

  • Growing demand for minimally invasive surgical solutions boosts Enovis's market potential.
  • Integration of digital health technologies opens new avenues for product innovation.
  • LimaCorporate acquisition expands Enovis's market share in the European orthopedic sector.

What critics are saying

  • Increased competition from Stryker and Zimmer Biomet in the orthopedic market.
  • Potential supply chain complexities from integrating LimaCorporate operations.
  • Regulatory challenges in obtaining FDA approvals for new products.

What makes ENOVIS unique

  • Enovis offers a diverse portfolio of orthopedic and reconstructive solutions.
  • The company integrates advanced materials like vitamin E-doped polyethylene in implants.
  • Enovis's acquisition of LimaCorporate enhances its transatlantic business capabilities.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Plan

Paid Vacation

Paid Sick Leave

Paid Holidays

Legal Services

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

30%

2 year growth

30%
MassDevice
Jan 17th, 2025
Enovis appoints new president of International Surgical business

Enovis (NYSE: ENOV) announced today that it appointed Davide Visentin as the new president of its International Surgical business.

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Jan 6th, 2025
Enovis to Participate in the 43rd Annual J.P. Morgan Healthcare Conference

Enovis to participate in the 43rd Annual J.P. Morgan Healthcare Conference.

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Jan 3rd, 2025
Confluence Investment Management LLC Makes New $3.49 Million Investment in Enovis Co. (NYSE:ENOV)

Confluence Investment Management LLC makes new $3.49 million investment in Enovis Co. (NYSE:ENOV).

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Nov 27th, 2024
Dynamic Technology Lab Private Ltd Makes New $1.05 Million Investment in Enovis Co. (NYSE:ENOV)

Dynamic Technology Lab Private Ltd makes new $1.05 million investment in Enovis Co. (NYSE:ENOV).

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