Quality Specialist (Bg)

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.

Quality Specialist

POSITION SUMMARY:

The Quality/Regulatory Specialist serves as a technical resource to meet quality and regulatory compliance demands within the medical device industry. These activities require good understanding of medical device quality system documentation and product marketing approvals for Class III medical devices.

SCOPE:

• Support the Corrective Action Preventative Action (CAPA) process for Quality within the Quality Management System (QMS)

• Drive root cause investigations in areas such as software products, services, complaints, audits, and customer feedback

• Lead cross functional discussions in pursuit of corrective actions to be applied toward process, training, or product issues

• Assign ownership of corrective actions and drive accountability within the business by creating and socializing reports, as well as tracking actions to completion

• Assess action effectiveness

• Provide training on root cause analysis techniques

• Assist with internal audits as required.

• Ensure conformance to industry practices, domestic and international regulatory requirements, and established company procedures. Manage overall Training & Qualification program across the organization, including but not limited to:

• Act as Global Training & Qualification SME, manage, and continuously improve the Training & Qualification Process

• Assures the integrity and reliability of information systems related to the Training & Qualification system; produces, analyzes, and distributes meaningful reports pertaining to the Training & Qualification processes

• Perform risk analysis, identify issues, and drive Training & Qualification compliance improvements using appropriate methodologies to ensure efficient regulatory compliance and increased effectiveness of training & Qualification programs

• Create, schedule & conduct training programs based on monthly and annual training calendar

• Keep the employees' records updated of their latest qualification and knowledge after training

SUPERVISORY RESPONSIBILITIES:

Performs supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include training employees; planning; assigning and directing work; evaluating performance; addressing complaints and resolving problems.

EDUCATION REQUIREMENTS:

• Bachelor's Degree in an engineering field or other technical science.

QUALIFICATIONS:

• 5 years prior experience in Quality Assurance and Regulatory Affairs

• Strong attention to detail

• Demonstrated experience working with regulatory bodies, contract manufacturers, suppliers and distributors.

• Comfortable working within a fast growth and changing environment

• Demonstrated ability to effectively communicate and influence decision makers.

• Experience in quality systems and audits.

• Knowledge of various Quality System and Regulatory Standards that are applicable to temperature-controlled logistics and transportation business elements and future GMP Compliance.

• Experience working in cross functional organizations.

• Strong communication and interpersonal skills.

• Excellent written and verbal communication skills with the ability to listen, articulate and advocate.

• Proactive, high performance result oriented and manage projects with ethical integrity.

• Manage multiple projects and deadlines

• Ability to identify compliance risks and escalate when necessary

• Demonstrate both creative and critical thinking skills

• Requires strong project management skills

• Requires strong continuous improvement skills

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is regularly required to stand, walk and sit. The employee frequently is required to use hands to finger, handle or feel objects, tools or controls and reach with hands and arms. The employee is occasionally required to stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and the ability to adjust focus.

WORK ENVIRONMENT:

While performing the duties of this job the employee is occasionally exposed to fumes or airborne particles. The noise level in the work environment is usually moderate.

COMPETENCIES:

• 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.

PERSONAL ATTRIBUTES:

• Passion and alignment with MVE's mission, vision, values & operating principles.

• Desire for working in a values-based company in alignment with a learning organization.

• A change agent and strong collaborator who is not afraid of challenging status quo.

• An individual who brings strong core values, quality, ethics, and integrity

• A collaborative team player who embraces and champions the culture

• Strong work ethic and ability to deliver results and meet commitments in a dynamic environment

• 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.

PREFERRED SKILLS:

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

• Understanding of GMP regulations

• Experience with IATA DG regulations, specifically Class 6.2, Conformite Europeenne requirements, etc.

• Experience with EDMS systems and implementation.