Senior Quality Engineer bei Cryoport

MVE Biological Solutions is the leading global manufacturer of vacuum insulated products and cryogenic systems. More than 50 years ago, they  set the standard for storage of biological materials at low temperatures. Today, they continue to exceed these standards. Industries from around the world look to MVE for excellence and innovation. Their solutions empower industries to better utilize cryogenic technology. In this manner, MVE continues to make a vital contribution in today’s biomedical life sciences industry.

POSITION SUMMARY:

The Senior Quality Engineer is responsible for organizing, planning, and directing activities related to the application and maintenance of quality standards for industrial processes, materials, and products. The focus is to continuously improve safety, quality, business, and manufacturing processes with an emphasis on eliminating process waste and optimizing business outcomes. Essential to this position will be to determine and drive root cause back to the source and implement corrective action to ensure the issue does not reoccur. The Senior Quality Engineer supports the Quality Assurance department by continuously maintaining and improving the Quality System in compliance with applicable regulations and standards.

This position will ensure product compliance to:

• 21 CFR Part 820,
• ISO 13485
• ISO 14971,
• MDD 93/42/EEC and
• EU MDR 22017/745 and 746

and will collaborate with cross-functional teams to maintain adherence to the Quality Management System during planning, execution, and implementation activities for Engineering initiatives.

PRIMARY RESPONSIBILITIES (include but not limited to)

• Support new product development, sustaining engineering, and cost-saving projects by ensuring compliance of project activities and documentation to internal QMS requirements as well as external regulations and standards (FDA, ISO, EN).
• Drive design assurance into medical devices as the Quality Lead during all stages of design controls projects through support of user needs, product requirements, design specifications, design verification and validation strategies, usability studies, and design reviews.
• Provide assessments and review for planning, execution and implementation of design and manufacturing changes for commercialized products.
• Responsible to generate and independently maintain project risk management file for NPD and sustaining projects. These include risk plans, hazard/failure mode effects analysis, risk mitigations and effectiveness checks, and risk management reports using principles from ISO 14971.
• Assist supplier quality, CMO, manufacturing, marketing and other stakeholders to generate risk assessments using Design, Process, Software FMEAs, FTAs, etc. per requirements of ISO 14971.
• Improve customer interfacing of products by direct analysis of impact through risk evaluation and prioritization of use errors per FDA's and IEC 62366 Human Factors and Usability Engineering for Medical Devices.
• Provide expertise in development and implementation of statistical support, inspection, sampling plans, test methods during Design Verification and Validation using a risk-based approach.
• Assist with annual post market surveillance activities (works with Technical Services, Customer Service, Engineering and Sales teams), ensures effective maintenance of the risk management program for commercialized products, and assess the need to implement design and process changes, where needed.
• Own applicable corporate quality policies and drive updates based on new standards or regulations for compliance, and/or process improvements for efficient use of QMS.
• Support product End of Life or decommissioning activities.
• Assist in training company employees on Quality Management System requirements.
• Apply technical problem-solving methodologies to identify, adapt to shifting priorities, communicate, and resolve quality issues.
• Assist with internal and external audits that include FDA, ISO and MDSAP.
• Provide assessment to resolve deviations and contribute to root cause investigations using various problem-solving techniques and tools for NCEs, CAPAs, Field Actions, Health Hazard Evaluations, and assesses effectiveness of corrective actions.
• Directly responsible for the daily supervision of the Quality Assurance Technicians.

COMPETENCIES & PERSONAL ATTRIBUTES:

• Establishing and maintaining Key Performance Indicators.
• Problem solving with a clear understanding of compliance requirements and the ability to collect objective evidence for investigations can help solve problems, typically in situations where general standardization should exist, but may not be operating effectively. 
• Team player with the ability and willingness to be involved in teams and meetings at every level of the organization. 
• Passion for, and alignment with, MVE’s mission
• An individual who brings strong core values, quality, ethics, and integrity
• A team player who embraces and champions the culture of collaboration and accountability 
• Strong work ethic and ability to deliver results and meet commitments in a dynamic environment
• A change agent and strong collaborator who is not afraid of challenging status quo.  
• Exceptional and dynamic communications skills with the ability to inspire and influence people at all levels, build consensus and commitment, and effectively drive change throughout the organization at a rate that fits the corporate culture
• Exceptional organizational and planning skills, strong analytical abilities, and process orientation.
• Desire to own decisions and take responsibility for outcomes.
• Willingness to travel when required.
• Willingness to continually embrace personal and professional development.

EDUCATION REQUIREMENTS:

• Bachelor’s Degree in an engineering field or other technical science plus 5 years related experience in supplier quality systems in a manufacturing environment OR
• Master’s degree plus 3 years related work experience required

QUALIFICATIONS:

• Experience in the medical device industry (manufacturing, engineering and/or technical capacity) required.
• In-depth knowledge and experience of 21 CFR Part 820 and ISO 13485 Design Controls required.
• FDA Class I and/or II medical device experience
• Medical device software experience preferred.
• Professional certifications (i.e., CQE, Six Sigma)
• Proven track record of success in a team lead or supervisory capacity, including direct experience with employee training and performance management.

PREFERRED SKILLS:

• Excellent computer skills including Microsoft office suite of products (Word, PowerPoint, Excel, etc.)
• Understanding of medical device regulations