What are the responsibilities and job description for the Senior Quality Engineer position at Actalent?
The Quality and
Regulatory Manager (QARM) will work leading a team supporting production and quality systems activities. The QARM will ensure consistent implementation of quality standards, maintain quality programs for existing products, and report to the VP of Operations on quality-related issues in an FDA regulated environment. In addition, perform duties as Person Responsible for Regulatory Compliance (PRRC).
Essential Job Duties and Responsibilities:
· Main duties and special projects as assigned:
o Responsible for the overall management of the Quality department.
o Responsible for management of Regulatory Affairs, including the oversight of external resources.
o Responsible for the hiring, development, management, and termination of the Quality team.
· The PRRC is responsible for ensuring that:
o The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before advice is released :
o The technical documentation and the EU declaration of conformity are drawn up andkept up to date
o The post-market surveillance obligations are complied with in accordance with the
requirement of the MDR
o Reporting obligations are fulfilled
· Product and Manufacturing Support:
o Support manufacturing engineering in process control, process validations, process improvement, process training programs, software control and validations, risk management
o Manage, Develop, apply, and maintain quality requirements and standards for manufactured products
o Design, implement, and evaluate quality processes, statistical sampling systems, inspection processes, test methodologies, and quality plans.
o Document and evaluate Nonconformance Reports (NCR); perform failure investigations, root cause analysis and risk determination for timely resolution
o Support validation activities; develop validation protocols, evaluate data and write reports
o Support special projects and continuous improvements efforts
o Perform engineering studies on new equipment to determine proper settings, control points, etc.; write and execute qualification protocols for equipment
o Lead teams to achieve common goals and results
· Quality System Support:
o Lead customer audits, interface with customer representatives concerning quality issues and assure that effective corrective action is implemented
o Serve as primary Quality Assurance Manager for problem identification, resolution, and continuous improvement such as required for nonconformance, corrective and preventive action programs
o Facilitate resolution of complaints, recalls, and customer feedback
o Provide metrics and prepare reports to evaluate effectiveness of Quality Systems
o Manage the Incoming Inspection process including inspectors performing the receiving inspection functions.
· Design Control Support:
o Lead design and development in design reviews, risk management, reliability, safety, hazard assessment, validation and qualification methods, and design transfers to manufacturing
o Develop, apply and maintain quality requirements and standards for design and development projects
o Lead validation issues specific to the product design
· Supplier Quality :
o Manage purchasing the evaluation and qualification of suppliers; establishing quality plans for suppliers, managing SCARS and performing supplier audits.
o Interface with suppliers to improve or resolve quality issues and assure effective corrective action is implemented; conduct supplier audits
· Change Control support:
o Review change requests to ensure that the necessary criteria and provisions are included in the quality and process plans
o Assist with establishing, implementing, and maintaining QMS processes to support cGMP requirements
o Perform on-site training for QMS procedures
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Salary : $90,000 - $120,000
