A Senior Quality Engineer is needed for a medical technology company focused on the repair, regeneration and replacement of soft and hard tissue in the Austin, TX area. The Senior Quality Engineer will ensure Quality Management System for orthopedic devices remains compliant with regulatory standards (FDA/ISO) by focusing on process maintenance, continuous improvement (CI), and measurement/analysis.
location: Austin, Texas
job type: Contract
salary: $39.28 - 46.42 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Lead the development and implementation of quality programs to ensure product and process conformity to specifications and regulations (20%).
- Drive continuous improvement efforts for Quality Controls to eliminate/reduce future recalls and ensure regulatory compliance (20%).
- Lead or participate in CAPA and non-conforming investigations, identifying appropriate actions and serving as the investigation Subject Matter Expert (SME) (20%).
- Work directly with cross-functional teams (Operations, Regulatory, PD, Supplier Quality) to ensure projects meet quality system requirements and support new product launches (20%).
- Lead or assist in gathering data and formulating strategy for risk-related activities (MSA, GRR, FMEA), and present statistics to facilitate business decisions (10%).
- Prepare strategy for and represent the site during internal and external audits (5%).
- Maintain the site's Quality Management System (QMS) compliance, focusing on process maintenance and measurement.
- Coach and mentor other engineers in the use of formal root cause investigation tools.
- Support onsite operational and inspection processes for orthopedic devices.
- FDA and/or ISO Regulations (strong working knowledge).
- Quality Inspection Experience (Top 3 Skill).
- Product Lifecycle Management (PLM) System proficiency (Top 3 Skill).
- ERP Systems Experience (SAP is a plus) (Top 3 Skill).
- Process Maintenance and measurement/analysis.
- Continuous Improvement (CI) methodologies.
- Root Cause Investigation Tools (Expertise to coach others).
- CAPA and Non-Conforming Investigations (Leading/Participation).
- Risk Management (MSA, GRR, FMEA).
- Bachelor's Degree in Engineering discipline.
- Six years of quality engineering experience.
- Experience with sterile medical devices and clean room activities is desired but not required.
- American Society of Quality (ASQ) certifications, such as Certified Quality Engineer, preferred but not required.
qualifications:
- Experience level: Experienced
- Education: Bachelors
skills:
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
