Quality Manager Key Responsibilities- Develop and scale the site's quality organization, including processes, structure, and capabilities.
- Support manufacturing readiness and quality compliance for a growing production facility.
- Establish, implement, and maintain a robust Quality Management System (QMS).
- Partner closely with site leadership to drive operational excellence and continuous improvement initiatives.
- Serve as the primary quality representative for the facility and collaborate with internal stakeholders across multiple locations.
- Lead quality activities including nonconformance management, corrective and preventive actions (CAPA), change control, risk management, and audits.
- Promote a strong culture of quality, compliance, and continuous improvement throughout the organization.
Qualifications- 7+ years of experience in Quality Assurance within a regulated manufacturing environment.
- Strong understanding of quality management systems, regulatory requirements, and industry standards.
- Experience supporting manufacturing operations and product quality in a production setting.
- Proven ability to lead investigations, root cause analysis, corrective actions, and continuous improvement efforts.
- Familiarity with quality tools and methodologies such as FMEA, SPC, Lean Six Sigma, DMAIC, 8D, and similar problem-solving frameworks.
- Experience within medical device, pharmaceutical, life sciences, advanced manufacturing, or other highly regulated industries preferred.
- Exposure to automated manufacturing processes is a plus.
- Strong communication, leadership, and stakeholder management skills.
Desired Profile- Entrepreneurial mindset with the ability to build processes and teams in a growing organization.
- Hands-on leader who enjoys working in a fast-paced, evolving environment.
- Strong sense of ownership, accountability, and execution.
- Collaborative and adaptable with excellent organizational skills.
- Results-oriented professional who can balance strategic initiatives with day-to-day operational needs.
- Demonstrated commitment to quality, compliance, and continuous improvement.
Additional Information- Opportunity to influence the development of a new manufacturing operation from the ground floor.
- High visibility role with significant growth potential.
- Competitive compensation and benefits package.
- Occasional domestic and international travel may be required.
Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits, and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria.Pay Details: $110,000.00 to $130,000.00 per year
Search managed by: Karla Hernandez
Equal Opportunity
Employer/Veterans/Disabled Military connected talent encouraged to apply
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