Find & Apply For Quality Control Systems Manager Jobs in Midlothian, Virginia

Are you a hands-on quality professional with experience in the medical device or pharmaceutical industry? Do you communicate confidently with regulatory authorities and pharmaceutical partners, bring people together around quality initiatives, and take ownership of solving problems? Are you willing to roll up your sleeves and do what it takes to build a strong culture of quality? If so, PARI may have an excellent opportunity for you. We are looking for a Quality Assurance Manager to lead and strengthen our quality systems, manage audit activities, and use quality data to drive accountability and continuous improvement. This is an opportunity for a practical, collaborative professional who takes pride in doing things right and understands that quality ultimately serves our customers and the patients who depend on our products. Who We Are PARI helps people breathe and improves their quality of life. For more than 120 years, we have manufactured, sold, and distributed medical devices with a focus on aerosol and inhalation technologies used in respiratory therapy. We are the gold standard in clinical trials and a trusted partner for innovative, effective inhaled drug delivery solutions. Our team believes deeply in our products and is committed to serving customers with excellence. This is the PARI way. About the Role We are hiring a Quality Assurance Manager to lead and coordinate quality assurance activities for PARI in the Americas, ensuring our products, processes, and systems meet applicable regulatory requirements and consistently deliver on our commitment to quality, safety, and our customers. In this role, you will oversee key elements of our Quality Management System (QMS), lead audits and continuous improvement initiatives, and work collaboratively with colleagues across the Americas and PARI Germany. You will have the opportunity to influence business decisions, strengthen quality practices, and contribute to the success of a global organization united by a common purpose. What It Takes to Succeed You will be joining a small, experienced team in the US. To thrive here, you must be: A strong professional communicator. You can represent the company confidently and professionally with regulatory authorities and pharmaceutical partners, lead productive discussions, and communicate quality expectations and issues clearly to internal teams, building buy-in. A practical problem-solver. You look beyond the immediate issue to understand root causes, evaluate risks, and implement sustainable solutions. You know how to balance regulatory requirements with the realities of day-to-day operations. A strong work ethic and sense of ownership. You follow through on commitments, pay attention to detail, meet deadlines, and take responsibility for ensuring quality issues are addressed effectively. A collaborative team member. You build trust, listen to others, welcome different perspectives, and work constructively across functions, locations, and cultures. A commitment to quality and continuous improvement. You recognize that quality is not simply about passing an audit. It is about maintaining reliable processes, protecting patients, meeting customer expectations, and continually improving how we work. Someone who will roll up your sleeves and embrace a "no job is beneath me" mindset. We are a small team in the Americas, and this role touches every part of our business. You are comfortable switching between strategic priorities and day-to-day execution, stepping in where needed, and working alongside colleagues to build a culture where quality is everyone's responsibility. No task is beneath you when it helps the team succeed. What You'll Do 1. Quality Systems Oversee and continuously improve the Quality Management System (QMS), ensuring compliance with applicable FDA requirements, including 21 CFR Part 820 (QMSR), ISO 13485, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Canadian Medical Devices Regulations (MDR), and other relevant standards. Manage quality system processes, including CAPAs, nonconformities, change control, document control, and quality records. Lead investigations into product quality issues and customer complaints, ensuring thorough root cause analysis, timely resolution, and effective corrective actions. Coordinate quality training and promote consistent understanding and application of quality procedures and regulatory requirements. Support

ISO 13485

certification and ongoing compliance through gap assessments, documentation, corrective actions, and related regulatory activities. Participate in adverse event reporting, product recalls, regulatory notifications, and follow-up activities as required. 2. Quality Audits Plan, lead, and execute the internal audit program to assess compliance, identify gaps, and drive continuous improvement. Serve as a primary quality interface with regulatory authorities, certification bodies, pharmaceutical partners, suppliers, and other external stakeholders during audits and quality-related discussions. Coordinate audit preparation, communicate requirements and expectations, and ensure timely, complete responses to findings. Partner with internal teams to investigate audit observations, develop corrective action plans, and verify the effectiveness of implemented solutions. Maintain readiness for regulatory and external audits by ensuring documentation, processes, and records are accurate, complete, and accessible. Build a culture of audit readiness, accountability, and proactive quality management. 3. Quality Reporting & Performance Maintain accurate, timely, and well-documented quality records and reports. Monitor quality metrics, CAPA progress, audit findings, customer complaints, and other indicators of QMS effectiveness. Analyze quality data to identify trends, assess risks, troubleshoot recurring issues, and recommend improvements. Lead regular Management Review meetings, presenting quality performance, significant issues, risks, and improvement opportunities to leadership. Communicate quality system performance and emerging concerns clearly to internal stakeholders and senior leaders. Ensure quality issues are escalated appropriately and that actions, owners, and deadlines are clearly defined and tracked through completion. 4. Communication, Collaboration & Leadership Communicate professionally and effectively with regulatory authorities, pharmaceutical partners, internal teams, and senior leadership on audits, quality matters, CAPAs, and improvement initiatives. Translate regulatory requirements and technical quality issues into clear, actionable guidance for employees and leaders across the organization. Build productive relationships across departments and with PARI Germany to align quality priorities, resolve issues, and support a One Team global mindset. Encourage open communication, listen to different perspectives, and help teams work through challenging quality issues constructively. Serve as a trusted quality resource and problem-solving partner, balancing regulatory compliance with practical business needs. Support continuous improvement and reinforce a culture in which quality, customer needs, and patient safety remain central to decision-making. What The Role Requires Bachelor's degree in a relevant field, such as Biological Sciences, Medical Technology, Quality Management, or Regulatory Affairs, or an equivalent combination of education and experience. Three to five years of relevant quality assurance experience in the medical device and/or pharmaceutical industry, or a similarly regulated environment. Experience working within a compliant Quality Management System. Practical experience with CAPA, internal and external audits, quality documentation, and regulatory compliance. Experience with regulatory submissions, audit responses, and quality reporting preferred. Working knowledge of FDA medical device requirements, including 21 CFR Part 820 (QMSR), ISO 13485, GMP, GDP, Canadian Medical Devices Regulations, and other applicable standards. Understanding of medical device and/or pharmaceutical quality systems, auditing practices, CAPA, root cause analysis, and continuous improvement. Familiarity with regulatory requirements for medical devices and drug-device combination products. Strong analytical, troubleshooting, and problem-solving skills, with the ability to interpret quality data and translate findings into effective action. What You Get in Return Excellent benefits and paid time off. A stable, mission‑driven organization. A supportive team of great people. Compensation The anticipated pay range for this position is $85,000 - $110,000 per year. Actual compensation may vary based on education, experience, skills, and geographic location. Pursuant to Virginia law, PARI does not request or rely on an applicant's wage or salary history when determining starting compensation. We are committed to an equitable and transparent hiring process. Equal Opportunity Employer PARI is an equal opportunity employer and considers all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status. If this role sounds like a great fit and you meet the qualifications described, we encourage you to apply immediately.

Job Type:

Full-time Pay:

$85,000.00 - $110,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Health insurance Health savings account Life insurance Paid time off Professional development assistance Referral program Relocation assistance Vision insurance Application Question(s): Describe any hands-on experience working within a regulated Quality Management System (QMS), including CAPA, nonconformities, and quality documentation? Describe how you have personally investigated a quality issue, performed or contributed to root cause analysis, and helped implement corrective actions to prevent recurrence? Describe your quality assurance experience in the medical device, pharmaceutical, or another FDA- or ISO-regulated industry? Describe how you have participated in or supported regulatory or external quality audits and communicated with auditors, regulatory representatives, or pharmaceutical partners regarding quality matters? Do you currently live in the Richmond metropolitan area or are you able to relocate to this area? Are you willing to work on-site?

Willingness to travel:

25% (Preferred)

Work Location:

In person