The Quality Assurance Engineer (QAE) provides guidance, expertise and services to ensure process and product quality of reagent products in Food & Feed Safety and Next Generation Sequencing. The QAE supports the enhancement and implementation of ISO 9001 quality system; internal auditing; material, process and production controls; and other aspects of quality assurance to ensure compliance to standards, regulations, and guidelines. The QAE works cross-functionally with R&D to support new product introduction; with manufacturing to create and modify procedures to ensure requirements are met; with purchasing to ensure incoming material meets specifications and suppliers to meet quality standards; and within Quality to ensure overall compliance and customer satisfaction.
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
- 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
- BS degree in life science with 2+ years’ experience in quality assurance role (preferred), Master of Science in similar discipline 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.)
- 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
- Qualified lead and internal auditor of ISO 9001:2015 QMS
- Specific product and application knowledge of MaxSignal, AuroFlow and NEXTflex product lines
- Application of concepts in continual improvement, Lean, 5S, Six Sigma, DOE, statistical analysis (Minitab, JMP software)
Physical Requirements (if applicable):
- Work is normally performed in a typical office work environment
- Possible exposure to mechanical, biologic and chemical hazards
Diversity is foundational to PerkinElmer and we know that hiring talent with different backgrounds will provide a greater impact for our customers and a more inclusive workplace for our team. Our commitment to creating a culturally diverse workplace is REAL! We know that it’s the people that make PerkinElmer a wonderful, enriching place to work that is why we are always searching for talented and motivated individuals to join the PerkinElmer Family.
So what’s in it for you?
We create a customized development plan to help you achieve your career goals. We partner with you to build a long and rewarding career by providing:
- On-the-job training
- Mentoring relationships
- Ongoing career development planning
- Company and external training programs
- Opportunities for internal career mobility
Our company fosters innovation, knowledge sharing, and teamwork for long-term success. We are committed to the development of your career, giving you opportunities to learn and grow. Simply put, we make a difference for you, so you can make a difference in the world.
We are passionate about our work and the benefits we create for our customers, our communities, and our environment. Every day, we help our customers work to create healthier families, improve the quality of life, and sustain the well-being and longevity of people globally.
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.
With about 13,000 employees worldwide, we pioneer scientific technologies for food and drug safety, environmental monitoring, industrial analysis, screening and diagnostic testing, and imaging for life sciences. We provide better detection, imaging, and informatics to help our customers make a profound impact on the world.