Director of Quality

Job description

About Rheo:
Rheo Engineering is a team of 90 engineers, craftsmen, and professionals building the powder handling systems and single-use containment solutions that help pharmaceutical manufacturers produce medicine safely, efficiently, and reliably. We're a critical link in the medicine supply chain - and we take that responsibility seriously. Our values - Bold Humility, Reliability, Collaboration, Competence, and Initiative - aren't just words on a wall. They shape who we are and who we hire.

The Role:
Quality at Rheo isn't a checkpoint at the end of the line. It's built into how we design, build, and deliver - and this role is responsible for making that real at every level of the organization.

We're looking for a Director of Quality to own and mature our Quality Management System, lead a team across QA, QC, regulatory compliance, and process validation, and serve as a trusted advisor to leadership on quality strategy and risk. This is a senior leadership role with real organizational authority and direct impact on our ability to serve the pharmaceutical, biotech, and life sciences customers who depend on us.

You'll report to the COO and work closely with Product Development, Engineering, Operations, and Supply Chain. If you're the kind of quality professional who approaches your work as a business enabler - not a bureaucratic function - this role is worth a serious look.

What You'll Own:
Data-Driven Quality Leadership & Risk Management
- Define quality KPIs aligned with business objectives and communicate performance trends to leadership on a regular cadence
- Apply statistical tools (SPC, capability analysis, root-cause analysis) and structured problem-solving methods (A3, DMAIC, 5-Why) to drive decisions
- Conduct ongoing risk assessments across the product lifecycle, manufacturing, supply chain, and customer interactions; implement FMEA at design, process, and system levels
- Maintain a robust nonconformance management and CAPA system; build early-warning metrics to enable proactive intervention
- Lead quality business reviews with the executive team covering QMS performance, validation status, risk posture, and business impact

QMS Development, Governance & Process Validation
- Build, implement, and govern a scalable QMS aligned with ISO 9001, ASME BPE, and FDA cGMP principles
- Ensure manufacturing processes are formally validated and maintained in a state of control
- Maintain a controlled library of SOPs, work instructions, specifications, and records appropriate to our size and growth trajectory
- Manage core quality processes: design control, process validation (IQ/OQ/PQ), supplier quality, testing and inspection, nonconformance, CAPA, internal audits, and management review

Regulatory Compliance & Customer Quality Excellence
- Ensure adherence to applicable regulatory requirements with focus on pharma, biotech, and life sciences expectations
- Lead interactions with regulatory bodies and customer quality teams; manage audits, inquiries, and change notices
- Execute and improve a customer audit readiness program; track and analyze customer feedback, complaints, and field returns to drive systemic improvement
- Maintain supplier quality agreements and performance monitoring; drive corrective action with strategic suppliers

Quality Culture & Team Leadership
- Drive a proactive, prevention-oriented quality culture where ownership is embedded across all functions
- Hire, develop, and lead team members across QA, QC, regulatory compliance, and process validation
- Serve as a trusted advisor to senior leadership on quality strategy, customer risk, and competitive positioning
- Partner with the Director of Continuous Improvement and cross-functional teams to reduce rework and scrap, and quantify the business impact of quality initiatives

What Success Looks Like:
- The QMS is audit-ready, well-documented, and genuinely followed - not just on paper
- Quality is understood as a business advantage across the organization, not just a compliance function
- The quality team is well-led, developed, and growing alongside the company
- Leadership has clear, reliable visibility into quality performance and risk

Minimum Qualifications:
Education
- Bachelor's degree in Quality, Engineering, Life Sciences, or a related discipline (or equivalent professional experience)

Experience
- 8+ years in quality roles, with at least 5 years leading quality teams
- Demonstrated experience building or significantly maturing a QMS in a regulated or customer-audited manufacturing environment
- Mastery of ISO 9001; familiarity with ASME BPE or equivalent standards; understanding of FDA cGMP expectations
- Proficiency in statistical methods and quality tools (SPC, FMEA, CAPA, DOE, root-cause analysis)
- Experience with quality information systems, data management, and metrics dashboards

Traits
- Strong communicator with the ability to influence across functions and organizational levels
- Data-driven and proactive - you anticipate risk and drive prevention over reactive fire-fighting
- Strategic mindset: you view Quality as a business enabler and measure your success in organizational terms
- Systems thinker with the ability to lead cultural change
- Customer-empathetic; balances high standards with pragmatism in a growing environment
- Accountable, collaborative, and transparent

Preferred Qualifications:
- Master's degree in Quality, Engineering, Business Administration, or a related field
- CQM certification or equivalent credential (e.g., IRCA ISO 9001 Lead Auditor)
- Experience in pharmaceutical, biotech, or medical device manufacturing; familiarity with single-use systems or containment equipment
- Experience with process validation, technology transfer, and product scale-up in a regulated environment
- Hands-on experience with IQ/OQ/PQ protocols, cleaning validation, or equipment qualification
- Experience with quality information systems (ERP integration, electronic batch records, document management systems)

Working Conditions:
- Primary work is at a desk and on a computer, with regular presence on the production floor for audits, inspections, and quality engagement
- Must be able to lift up to 15 lbs. at times
- Travel required for supplier audits, customer meetings, and industry engagements
- Responsiveness to urgent quality or compliance matters outside normal business hours may be needed

Benefits:
- Medical Insurance (multiple plan options, including PPO and High Deductible plans) - Rheo covers 85%+ of the cost!
- Dental Insurance
- Vision Insurance
- HSA with Employer Contributions (for qualifying plan enrollment)
- Company-paid Term Life & AD&D Insurance with options for additional Voluntary Life coverage
- Short-Term & Long-Term Disability
- 401(k) with 4% Employer Match
- Generous PTO (starting at 16 days for salaried) + 10 Paid Holidays, growing with tenure
- Paid Maternity (6 weeks) and Paternity (2 weeks) Leave
- T-Mobile Phone Plan paid by Rheo + $750 smartphone stipend every two years
- Identity Protection through Aura Identity Guard
- $500 Employee Referral Bonus Program
- Equipment reimbursement (safety footwear, prescription safety glasses)