Job Title:
NPI Quality Engineer
Reports To:
Sr. NPI Quality Manager
Location:
Houston, TX
Business Unit Description:
Foot & Ankle
Job Title/High-Level Position Summary:
Utilizing a comprehensive knowledge of engineering and problem-solving principles, this position is responsible for a variety of complex activities regarding the design, implementation, and maintenance of quality assurance procedures and work instructions to ensure external safety, quality, and compliance with complex Company standards and government regulations.
This position primarily supports New Product Development, Sustaining Product Development, and Complaint Investigations and serves as the QA representative on various PD initiatives.
Key Responsibilities:
- Participating in design and manufacturing reviews
- Generating DFMEAs/UFMEAs and participating in risk analysis discussions
- Develop inspection strategy and methods to support the development and launch of new products.
- Reviewing and approving design and development documentation
- Serve as subject matter expert for design quality in ISO and FDA audits
- Authoring procedures and work instructions that define and govern the quality system
- Conduct internal audits of the quality system and other business functions
- Evaluating nonconforming material and dispositioning based on cross-functional engineering review
- Assuring compliance to internal and external specifications and standards (i.e. GMP, ISO, FDA, MDD)
- Reviewing trends in device failures associated with customer complaints and nonconforming material
- Leading and owning corrective and preventive actions and complaint investigations
- Working on complex special projects as assigned
Currently, Enovis does not provide sponsorship for employment visas (e.g., H-1B) and will not offer such sponsorship in the future. Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship.
Minimum Basic Qualifications:
- Bachelor’s degree in Biomedical or Mechanical Engineering and 5+ years of experience (or equivalent combination of education and years of experience).
- Background in Medical Device, Aeronautics, Automotive or other highly regulated industry required; preferred knowledge of ISO13485 quality standards.
- Knowledge of technical writing quality and best practices.
- Required basic knowledge of manufacturing processes: key focus into metrology, precision machining, grinding, product cleaning, and sterilization.
- Individual should have knowledge of Microsoft Office Suite of software or equivalent.
Travel Requirements:
Desired Characteristics:
- Advanced knowledge of ISO 14971 and risk management principles
- Experience with Class II/III Medical Devices
- Preferred knowledge of the following: Solidworks, Solidworks ePDM, MiniTab, Netsuite, Agile PLM, CMM and/or automated inspection system programming.
- Prefer CQE, Lean, or 6 Sigma Certification.
- Detail oriented and analytical
Enovis values the contribution each employee brings to our organization. The pay range listed is what we reasonably and in good faith expect to compensate candidates who meet the specified qualifications and requirements for this role. Actual starting pay will depend on various factors, including but not limited to education and experience in the job and/or industry.
Base Pay Range: $86,520 - $94,760 - $104,174 (reflective of a full-time position)
Employees in this position are also eligible to earn an annual performance bonus.
We offer a comprehensive benefits package that includes:
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Spending and Savings Accounts
- 401(k) Plan
- Vacation, Sick Leave, and Holidays
- Income Protection Plans
- Discounted Insurance Rates
- Legal Services
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