Quality Manager in Ormond Beach, Florida at Germfree Laboratories Inc
Job Description
Job Title: Quality Manager
Department: Quality Assurance
Reports To: Director of Quality & Lean
Location 4 Sunshine Blvd, Ormond Beach, FL 32174
Employment Type: Full-time, permanent
Work Environment: Production and receiving environment
Job OverviewThe Quality Manager will establish, oversee, and manage the Quality and Continuous Improvement programs at Germfree. They will provide leadership to establish and maintain quality levels that meet and exceed customer expectations and will drive Continuous Improvement Initiatives that improve the business overall.
The Quality Manager directs all quality activities across the modular and mobile cleanroom design, manufacturing, quality control inspection, and factory acceptance testing process. In partnership with the VP of Quality and Regulatory, the Quality Manager ensures Germfree products are consistent with specifications and that the vision for quality products and services reflects Germfree's values and objectives.
The Quality Manager is responsible for leading standard methods for inspection, testing, and evaluation, using knowledge of quality control processes and engineering disciplines in mechanical, electrical, structural, instrumentation, and process controls.
Essential Duties- Lead, manage, and direct the quality and quality control function to ensure quality standards are independently verified throughout all phases of design and construction.
- Develop and manage formal QA/QC Standard Operating Procedures (SOPs).
- Oversee the development of project-specific Quality Plans in accordance with project requirements and industry’s best practices.
- Implement and maintain the programs that support the Germfree Quality Policy, the Quality System, and Continuous Improvement Initiatives (CII).
- Coordinate investigations of internal and external customer quality issues to ensure timely, closed-loop corrective actions.
- Conduct supplier audits as needed to meet objectives.
- Drive efforts to reduce cost of quality (COQ) and improve other key metrics.
- Partner with Production and Engineering to create and direct programs that ensure product quality.
- Participate in lessons-learned sessions, operational development initiatives, and best-practice training to support a continuous improvement in culture.
- Manage external audits and inspections by certification bodies, customers, and authorities.
- Lead the initiation and implementation of continuous improvement process (CIP) measures.
- Develop and maintain an integrated management system that meets ISO 9001 requirements.
- Monitor defined quality objectives and prepare regular key performance indicator (KPI) reports on the status of the quality management system.
- Support skill development across teams by providing training, guidance, and constructive feedback on quality practices.
- Build strong quality processes to determine the infrastructure and resources needed to achieve business objectives.
- Share quality information companywide and promote quality initiatives.
- Bachelor's degree or equivalent in engineering, construction management, construction science, or life science.
- 5 years of quality management experience in construction or a related field.
- Professional experience in quality planning and in strategic and operational quality management in accordance with ISO 9001.
- Strong knowledge of ISO 9001 certification requirements.
- Knowledge of and experience in a GxP environment and with risk-based process design.
- Excellent understanding of quality processes and manufacturing operations.
- OSHA 10 certification (or obtained within the first 3 months of hire).
- U.S. Army Corps of Engineers (USACE) Construction Quality Management (CQM) for Contractor’s certification (or obtained within the first 3 months of hire).
- Experience with pharmaceutical cleanrooms and/or laboratories.
- Knowledge of design-build construction contracts.
- ASQ certification: Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or Certified Quality Auditor (CQA).
- Excellent technical writing and verbal communication skills.
- Strong leadership and organizational skills, with the ability to adjust priorities in a rapidly changing environment.
- Strong time management and attention to detail.
- Team players who can also work independently to meet deadlines, goals, and objectives.
- Highly motivated, with a passion for excellence and a habit of taking initiative.
- Strong work ethic and commitment to getting the job done right the first time.
- Demonstrated commitment to ethics and integrity.
- Proficient in Microsoft Office (Word, Excel, Outlook) and other standard business software.
- Supervision required: Minimal; able to work independently.
- Supervisory responsibilities: None.
- Regularly required to stand, walk, and use hands to operate objects, tools, or controls; reach with hands or arms; and climb, balance, stoop, kneel, or crouch as needed.
- Must be able to lift and/or move up to 40 pounds.
- Vision requirements include close, distance, and peripheral vision, color perception, and the ability to adjust focus.
- Regularly works near moving mechanical parts and may work with chemicals.
- Travel to client locations is required, up to 25%, including some international travel.
Germfree is committed to employee well-being, growth, and work-life balance. We provide a supportive environment, strong benefits, and the tools you need to succeed.
Insurance and Benefits- Medical, dental, and vision insurance
- Short- and long-term disability
- 401(k) with company match
- Employee referral bonuses
- 80 hours of paid holidays, including year-end shutdown
- Generous paid time off (PTO)
Germfree is proud to be an Equal Opportunity Employer committed to fostering a diverse and inclusive workplace. We value and celebrate the unique backgrounds, perspectives, and experiences of all individuals, and we believe that diversity drives innovation and growth. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected status.
Germfree maintains a drug-free workplace. Offers of employment may be contingent upon successful completion of drug screening, in accordance with applicable laws and company policies.
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