What are the responsibilities and job description for the Development Quality Engineer position at Actalent?
Job Description:
- Participate in or lead teams in supporting quality disciplines, decisions, and practices,
- Lead on-time completions of design control deliverables,
- Support on-time execution of Quality Plans for internal product development process (PDP), OEM-based Clinical Product Development (CPDP) and design change projects,
- Accountable for generation of PDP design verification test plans/reports for product/system requirements,
- Lead or support Risk Management activities from product concept through commercialization, including generation of risk management plans/reports, completion and maintenance of hazard analysis, FMECA's and Cybersecurity risk assessments,
- Lead identification of essential outputs and generate Essential Output reports,
- Accountable for completion of labeling verification activities and labeling verification reports,
- Work with design engineering in the completion of customer/system/product requirements,
- Work with design engineering in the completion of product verification and validation,
- Endure DHF content completion, integrity and regulatory & standards compliance, collaborative communication resolving gaps,
- Complete document change request reviews in a timely and objective manner,
- Identify and implement effective process control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements,
- Assist in the implementation of assurances, process controls and CAPA systems designed to meet or exceed internal and external requirements,
- Assist in tech development and execution of streamlined business systems which effectively identify and resolve quality issues, apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues,
- Support all company initiatives as identified by management and in support of quality management systems (QMS), Environmental Management Systems (EMS) and other regulatory requirements,
Experience Level:
Years Experience: 2-5
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
