Senior Quality Assurance Engineer
ResponsibilitiesLocation Austin, TexasUS Job ID JR-022796
Imagine a world where you could detect health issues sooner to treat them more effectively. Where food and water are always safe, even in remote corners of the earth. And where scientific and medical research are enhanced to solve the greatest challenges of our times. At PerkinElmer, we imagine this world every day. Then, we innovate and collaborate to make it happen everywhere.
Our dedicated team of about 14,000 employees worldwide, pioneers scientific technologies for better detection, imaging, and informatics to help our customers work to create healthier families, improve the quality of life, and sustain the well-being and longevity of people globally.
If you are seeking a meaningful, impactful, and stimulating career, look no further.
Essential duties and position responsibilities:
- Together with Management drives an organizational culture of quality
- Support CAPA program, NCM and Deviation administration
- Conduct internal audits and support third party audits to ISO 9001 QMS
- Supports regulated inspections to EUA requirements
- Complaint handling, quality investigations and management of customer feedback
- Coordinate equipment maintenance and calibration activities, both third party and in-house
- Use of software to generate metrics for quality trending
- Data entry into quality system management software QCBD
- Engage with document revision/approval process
- Assistance and data contribution for management review
- Manage supplier quality qualification and evaluations
- Maintain records organizational systems, including basic indexing and filing
- Other duties as assigned by management
- Bachelor’s degree in life sciences with 5 years of quality assurance experience OR
- Master’s degree in life sciences with 3 years of industry experience
- Previous experience in an ISO 9001, 13485 or GxP compliant manufacturing environment
- Previous experience with quality management system software for quality data tracking and document change management (e.g. TrackWise, MasterControl, Agile, QCBD, etc.)
- Qualified lead and internal auditor of ISO 9001:2015 QMS
- Product and application knowledge of life science products and molecular biological lab techniques
- Application of concepts in continual improvement, Lean, 5S, Six Sigma, DOE, statistical analysis (Minitab, JMP software)
- Proficient in using Microsoft Office suite including Excel, Word, PowerPoint
- Strong written and verbal communication skills
- Positive, people-oriented, energetic attitude; able to work in a fast-paced environment
- Self-motivated, highly organized, and able to prioritize and manage multiple tasks
Physical Requirements (if applicable):
- Performs work on site in Austin, Texas
- Work is normally performed in a typical office work environment
- Possible exposure to mechanical, biologic and chemical hazards
- Must adhere to additional PPE and safety controls to prevent the spread of COVID-19
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time.
PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.
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