Quality Assurance Engineer-Validation

Job Description:

At Enovis™ we pay attention to the details. We embrace collaboration with our partners and patients, and take pride in the pursuit 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. Why work at Enovis? See for yourself.

As a key member of our 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 - Validation

Reports To:

Sr. Quality Program Manager

Location:

Austin, TX

Business Unit Description:

Surgical Process Validation

Job Title/High Level Position Summary:
 

Working cross-functionally, conduct technical and complex quality analysis and tests of quality control program and recommend necessary quality procedure changes. Record and analyzes customer claims and prepare reports on rejected or defective products. Assist in the development of new methods and procedures.

Essential Responsibilities:

• Involvement in the Master Validation Plan (IQ, OQ, PQ) regarding validation and verification Processes
• Participate in continuous improvement activities to enhance quality systems, such as 5S, Kaizen lean methods, etc.
• 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 (QMS).
• Participate in audits, including Notified Body Audits, FDA inspections and other 3rd party audits as well as closingout audit findings, creating audit finding reports and determine proper corrective and preventive actions.
• Analyze failure, corrective and preventive actions needed to respond to customer complaints/supplier failures.
• Maintain company quality documentation, such as quality manuals, quality procedures, etc.
• Maintain Nonconformance System and the COPQ Initiatives.
• Facilitate and Manage Gage R&R, SPC and capability requirements
• Participate on launch and current production engineering changes
• Supports Incoming Inspection; help maintain files and backup supplies for inspection.

• 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:

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:

• A bachelor’s degree in engineering or other technical discipline degree is required
• A minimum of 2 years of experience in quality engineering or related field with, with focus on, process validations, product development supports
• Previous knowledge of FDA/GMP, CMDR, MDD and ISO 13485 quality standards.
• Experience with Quality related tools (D and P FMEA, QFD, SPC, Risk Analysis, DOE, and TQM)
• Previous experience with Microsoft Word, or equivalent word processing software; Excel, or equivalent spreadsheet software, as well as statistical analysis and data base searches. 

Desired Characteristics:

Certifications, Skills, Competencies

• Previous 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.
• ASQ certification with active local membership is preferred.
• Lean Six Sigma Green Belt or higher preferred.
• Ability to understand and interpret drawings and data – GD&T knowledge to interpret mechanical part drawings, assembly drawings, block and flow diagrams, and BOMs
• 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.
• Application and implementation of regulations such as GMP/QSR/ISO/MDD and C