Quality Systems Engineer

SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5,000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the United States.

Job Overview

Develops, establishes, and maintains the quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards and regulatory agency guidelines to ensure continued customer satisfaction. Provides leadership that results in the implementation and achievement of the quality policy and functional objectives including initiatives in conjunction with the Senior QMS Manager

Main Responsibilities

• Implement and maintain Charleston site Quality Management System in accordance with ISO 13485 and FDA regulations.
• Coordinate, compilate and present Site Management Review. Responsible for trending/analysis of KPI data based on SOPs for recording, evaluation and reporting of Quality and reliability data.
• Responsible for the implementation, co-ordination, and continuous review of the CAPA system.
• Facilitation of CAPA management in other areas of the organization.
• Work with Quality and other leaders to identify areas within the quality system in need of improvement and manage Corrective and Preventive Actions as appropriate.
• Oversee the nonconforming material process and execute root cause analysis and investigative writing training as needed.
• Maintain and monitor Change Control process. Own and process change control records, as appropriate.
• Assess and respond to Customer Complaints within the requirements of local procedure and/or Quality Agreements. Oversee the Document Management process including execution of training per applicable training matrix.
• Plan, coordinate, and conduct scheduled internal audits to assess compliance with FDA, ISO, other applicable standard requirements, and internal requirements.
• Supports efforts regarding external audit preparation, execution, and closure activities for each audit. Interfaces directly with Quality System Process and Sub-Process owners, Subject Matter Experts, and Management and Global Quality Systems personnel, as needed, to ensure functions are clear regarding scope of each audit and expectations of readiness to support all audits involving those functions. Responsibilities include logistical preparation such as developing audit support staffing plans, communicating status of audit preparation, and leading preparation meetings with SMEs.
• Perform backroom activities for Quality System external audits.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities.
• Perform additional tasks as needed for the support Production systems (MES, SAP)

Skills and Qualification

• Bachelor’s degree in Life Science or equivalent
• Minimum of 5 years’ experience in Quality Assurance or medical device field
• Demonstrated leadership & people management experience within a functional management role.\
• Comprehensive understanding of the QSR, cGMP and ISO/MDD standards.
• Excellent communication skills with the ability to influence others.
• High level of initiative & autonomy through continuous questioning of current practices.
• Fluent in English.
• Effective team member, motivated to achieve and demonstrate best practices in line with the department & global objectives.

We Offer

• Competitive compensation package
• Modern working environment with state-of-the-art facilities and technologies
• Challenging assignments in a fast-growing and innovative industry
• Position in a dynamic, international team of highly skilled professionals
• Various opportunities for personal and professional development within a global organization

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application including your CV, motivation letter, and all other relevant documents to our Talent Acquisition Department at RecruitUS@shl-group.com.

For more information on SHL Medical, please visit: shl-medical.com