Medical Device Quality Assurance Engineer

Enovis•Austin, TX

15h•Onsite

About The Position

Utilizing 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 directly supports Operations/Manufacturing and serves as the QA representative on the Material Review Board.

Requirements

Bachelor’s in Science or Engineering
7-10 years of experience.
Experience with manufacturing transfers and validation (IQ/OQ/PQ) in a regulated environment required.
Background in Medical Device, Aeronautics, Automotive or other highly regulated industry required; preferred knowledge of ISO 13485 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.
Must be able to communicate in English clearly and fluently, in both written and verbal skills
Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship.

Nice To Haves

Preferred knowledge of the following software packages: Solidworks, Solidworks ePDM, Oracle R12, Agile PLM.
Prefer CQE, Lean, or 6 Sigma Certification
Accurate and professional telephone communication
Accurate and professional written communication (email, text and formal letter)
Must possess professional ethics and demeanor
Must demonstrate excellent customer service.
Computer skills (Excel, Word, Power Point).

Responsibilities

Evaluating Nonconforming material and dispositioning based on cross-functional engineering review
Performing analysis of reports and production data to identify trends.
Initiating, developing and recommending updates or changes to quality standards and procedures.
Authoring and conducting process and equipment validations
Assuring compliance to internal or external specifications and standards (i.e. GMP, ISO, FDA, CMDR).
Reviewing trends in device failures associated with customer complaints and nonconforming materials.
Leading root cause analysis.
Leading in corrective and preventive action investigations.
Support Manufacturing and Operations to remedy adverse quality or compliance situations.
Working on complex special projects as assigned.