Quality Investigator

Quality Investigator
Contract to hire
Austin, TX
Hourly Rate: $30/hr
Shift: M-F, 8am-5pm

Orion Group is seeking a detail oriented and analytical Quality Investigator to work onsite in Austin, TX for our Medical Device Manufacturing client. This is an exciting contract-to-hire opportunity and you will be working with a Global Life Sciences industry leader!

Job responsibilities:
* Conduct and write formal investigations for plant quality issues.
* Perform impact assessments and investigate to the depth commensurate with the identified risk.
* Provide quality consulting (to include investigations, assist in root cause determination, and assist in identification of appropriate Corrective Actions and Preventive Actions) to support plant and corporate activities.
* Assure changes are implemented in associated plant procedures as corporate guidelines involving investigations are updated.
* Assist in the tracking and trending of corrective and preventive actions for plant quality issues to assure timely closure.
* Remain current in regulatory expectations and industry practices regarding investigations and CAPA. Review and evaluate sensitive, confidential information and develop recommendations for use by plant quality.

Requirements:
* Bachelor's Degree, preferably in a technical discipline (Engineering or Science) required, ASQ certified Quality Engineer, preferred.
* Must have experience in Pharma, Medical Device or similar regulated industry.
* Must have at least 5 years of relevant experience
* Strong oral, written, communication, presentation and interpersonal skills.
* Typically interface with multiple levels of people within the organization, including corporate management and plant personnel.
* Superior technical writing and problem solving skills required.
* Must be capable of organizing data from multiple sources, extracting key information and writing technical reports and executive summaries.
* Experience with word-processing, spreadsheet and presentation software (e.g., Microsoft Office).
* Experience using data analysis computer tools and statistical analysis tools is required.
* Experience working in a cross-functional, matrix environment.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.