The position of Principal Quality Specialist is within our client's Informatics business located in Charlottesville Virginia. This role provide quality oversight and leadership by proposing and implementing process improvements and maintaining and improving various quality system processes. Conceive, plan, design, conduct and lead quality activities. Train others and advance the state of cGMP and compliance knowledge of the organization.Makes independent decisions within broad parameters while assuring that these decisions are compliant with site level policies and procedures, aligned with the quality system and consistent with regulatory requirements and business objectives.

This job function has accountability for complying with the applicable elements of Global Quality and our client's Quality Management System (QMS)

This job description will be reviewed periodically and is subject to change by management.

RESPONSIBILITIES:

• Monitor and improve existing QMS processes to streamline and ensure compliance. Identify key process indicators, analyze and report relevant metrics for these processes to management.
• Administer the electronic Document Management System(s) to ensure efficient organization, review, approval & delivery of documents, training of all users, implementation and validation of new system or upgrades to existing system, and compliance with all applicable standards. Writes, reviews and approves Quality System documents as necessary.
• Administer the electronic training program to ensure adequate quality/regulatory training of all personnel. Works with management to define & document required quality training as part of the overall training program.
• Supports quality management by participating in other quality system processes, including audits, complaints and non-conformance. Acts as the Quality representative on cross-department and/or site teams, such as product development and design control.
• Actively participate in or facilitate audit and self-assess routine maintenance of ISO 13485 cGMP requirements. Facilitate external (ISO/FDA) audits.
• Apply established quality and engineering methods to the investigation of product and process failure. Provide technical expertise in root cause analysis and statistical techniques to identify solutions to a range of problems. Performs CAPA (Corrective Action Preventive Action) and FCA (Field Corrective Action).
• Investigates and analyzes impact of product and process failure. Use technical, compliance, product and process knowledge to assist in identifying preventative actions. Able to assure effectiveness of actions are taken to prevent re-occurrence.
• Demonstrate awareness of changes in the quality and regulatory environment. Utilize good judgment and make timely decisions which consider the facts and data at hand. Champions specific projects, knowing when to escalate to management.
• Understand and assess the impact of a change on the safety and efficacy of a software product, device, process performance, and internal/external customer expectations worldwide.
• Lead Risk Management activities. Assess internal and external risks associated with specific actions, quantify risks, seek input from others, and takes actions to limit the exposure to the business.
• Develop local strategy in alignment with the business goals and implements related tactical activities. Translates strategic needs into executable plans.
• Follow and contribute to policies and procedures. Gather data for and contribute to establishment of quality metrics for the unit. Monitor and takes corrective action for processes and systems;

BASIC QUALIFICATIONS | EDUCATION:

• 4 year degree in a scientific or technical discipline preferred or 10+ years of experience in a related field.
• 5 or more years in a regulated environment, preferably in medical devices with excellent understating and knowledge of quality system processes.
• Working knowledge and experience with FDA, cGMPs/QSR and ISO Quality System requirements.
• Strong analytical skills, ability to organize work in a logical and thorough manner.
• Able of analyzing data to support the development of strategies to effectively manage, enhance, mitigate, and/or resolve potential issues.
• Demonstrate problem-solving skills. Identify and resolve problems in a timely manner. Work collaboratively in group problem solving situations.
• Extrapolate meaningful and defensible conclusions from limited data using analytical methodologies, integrate complex data and identifies critical process variables.
• Demonstrates project management skills
• Highlights issues in a timely manner and presents possible resolutions. Seeks additional information when problem is beyond area of personal expertise.
• Flexibility to adapt to changing assignments and ability to effectively prioritize.
• Excellent written and oral communication skills with ability to interact with all levels of internal/external customers and third-party vendors.

PREFERRED QUALIFICATIONS:

• Advanced understanding of compliance, cGMP and product developmen.
• Able to prepare, analyze and present Key Performance Indicators (KPIs).
• American Society for Quality (ASQ) certifications a plus.

COMPETENCIES:

• Works in a collaborative, fast-paced, goal-driven environment.
• Possesses interpersonal skills to negotiate and reconcile differences. Removes barriers that block goal attainment
• Able to work independently and report efforts. Takes personal responsibility to resolve issues.
• Demonstrates accountability for complying with local and global Quality System requirements.
• Helps drive and promote understanding of the need for change through the organization.
• Influence outcomes appropriately, influences others to support a course of action, influences activities without reliance on formal authority
• Provide mentoring in quality, compliance, and technical areas across multiple work groups. Provides constructive and timely feedback to ensure compliance and mitigate risk.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.