Quality Assurance & Document Control Specialist
Job Level: P2
Work Location(s): Chadds Ford, PA (Greater Philadelphia Area)
Relocation Assistance: Not Available
Visa Sponsorship: Ineligible
At MOBILion Systems, you’ll join a dynamic team committed to positively impacting healthcare by commercializing products that help people and save lives. Our products provide unprecedented sensitivity, resolution, and throughput that fuel the development of better therapeutics, the ability to detect disease earlier, and the power to attack diseases at their roots instead of their symptoms. Our technology reveals what others leave unseen!
This is an opportunity to join an outstanding and growing team with an inclusive culture that delivers meaningful insights to the entire company!
This position will assist with maintaining compliance to ISO 9001 processes and procedures within the Company’s Quality Management System under the direction of the Director of Quality. Additional areas of responsibility include developing, implementing, maintaining, and assisting in auditing quality assurance processes for compliance to ISO 9001 and ISO 13485. Responsibility for Document Control and employee training managed using an electronic QMS system is also an integral part of this opportunity.
- Support and maintain continuous improvement activities with cross-functional team members.
- Monitor quality processes through Internal audits and support external audit activities
- Review responses to audit findings for completeness and effectiveness to support continuous improvement efforts
- Support KPI evaluation and analysis for Management Reviews
- Support effective corrective action and preventive actions (CAPA) processes, including but not limited to assisting with the tracking, trend analysis, root cause analysis, and implementation of process improvement measures and effectiveness checks
- Provide support during external audits
- Assist with creating and tracking approvals for new procedures, work instructions, and forms related to ISO 9001 requirements
- Assist with the implementation of an electronic quality management system
- Assist in maintaining the document control and related quality functions in the electronic QMS (eQMS)
- Perform Document Control functions including adding new documents to the eQMS, initiating the approval process, managing document release, and initiating document training within the eQMS
- Assist in the analyses, metrics, and continuous improvement with respect to business objectives and in compliance with ISO 9001
- Bachelor’s degree preferably in the sciences and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience
- Strong understanding of quality system principles and requirements per ISO 9001
- Experience in Document Control
- Experience with internal and/or third-party quality audits
- Internal auditing experience
- Excellent written and verbal communication skills
- Ability to manage multiple priorities and triage accordingly with accuracy and a high attention to detail
Preferred Skills & Qualifications:
- CQA Certification
- Experience using Arena or an electronic QMS
- Understanding of quality system principles and requirements per ISO 9001 and ISO 13485
Our vibrant culture is built on shared values and our passion to positively impact healthcare. We foster amazing teams and have a bias toward action. We encourage everyone to bring their whole selves to work and grow together through development opportunities, mentorship, and shared successes. We’ve also got amazing benefits!
- Healthcare insurance for employees and their families
- Rich 401(k) offering with Company match
- Annual bonus potential
- Employee Stock Ownership program
- Generous paid time off benefits with paid year-end business closure
- Flexible work arrangements
- Onsite fitness center
- Free snacks and beverages
- Energetic & inclusive culture
MOBILion Systems is proudly committed to recruiting and retaining a diverse and inclusive workforce. As an Equal Opportunity Employer, we never discriminate based on race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical condition), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.