Design Quality Engineer at Enovis

Job Title/High Level Position Summary :
This position primarily supports New Product Development and Sustaining Product Development and serves as the QA representative on various PD initiatives.
The following are the primary duties and responsibilities of this role. Other related duties may be assigned to meet business needs.
Particular focus on supporting sustaining and special instrument teams
Participating in design and manufacturing reviews
Generating DFMEAs/UFMEAs and participating in risk analysis discussions
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
Working on complex special projects as assigned
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.
Bachelor's in Biomedical or Mechanical Engineering and 3+ 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:
Up to 10%
Desired Characteristics:
Preferred knowledge of the following software packages: Solidworks, Solidworks ePDM, Oracle R12, Agile PLM.
CQE, Lean, or 6 Sigma Certification.
Advanced knowledge of ISO 14971 and risk management principles
Detail oriented and analytical
Physical Requirements:
Ability to sit/stand for long periods of time
Life sciences quality/regulatory industry experience desired (medical devices, pharmaceutical or biotech)
Certifications, Skills, Competencies
Advanced proficiency in Microsoft applications, particularly Excel and Word.
Working knowledge of US and International quality system regulations.
Strong interpersonal communication and teamwork skills.
Excellent organizational, prioritization, and communication-skills (written and verbal) required.
Fluent in English (oral and written); additionally, Spanish, German, and/or French-speaking is a plus.
Work Environment:
General office setting. The office is clean, orderly, and properly lit and ventilated. Noise levels are considered low to moderate.
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Design Quality Engineer

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