Quality Manager

GERMFREE LABORATORIES INC; Ormond Beach (FL); In loco; USD 90.000 - 140.000; Tempo pieno

Vantaggi offerti da questo lavoro

401(k) with company match

Medical, dental, vision insurance

PTO and paid holidays

Descrizione del lavoro

Germfree Laboratories Inc is seeking a Quality Manager to lead the Quality Assurance and Continuous Improvement programs at its Ormond Beach facility. You will oversee QA/QC activities across design, manufacturing, inspection, and testing, ensuring products meet specifications and customer expectations.

Responsibilities include developing SOPs, leading audits, coordinating CAPA, and driving CIP initiatives with cross-functional teams.

Competenze

• 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.

Mansioni

• Lead, manage, and direct the quality and quality control function across all project phases.
• Develop and manage formal QA/QC SOPs.
• Oversee development of project-specific Quality Plans per requirements.
• Implement and maintain programs that support the Germfree Quality Policy and Quality System.
• Coordinate investigations of internal and external customer quality issues to ensure corrective actions.
• Conduct supplier audits as needed to meet objectives.
• Drive efforts to reduce cost of quality and improve metrics.
• Partner with Production and Engineering to ensure product quality.
• Participate in lessons-learned and CIP initiatives to support continuous improvement.
• Manage external audits and inspections by certification bodies, customers, and authorities.

Conoscenze

Quality management

Leadership

ISO 9001 knowledge

Quality assurance

Documentation

Formazione

Bachelor's degree in engineering

Strumenti

Microsoft Office

Descrizione del lavoro

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Quality Manager

Quality Full Time Ormond Beach, FL, US

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 Overview

The 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.

• 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.

Other Duties

• Build strong quality processes to determine the infrastructure and resources needed to achieve business objectives.
• Share quality information companywide and promote quality initiatives.

Education

• Bachelor's degree or equivalent in engineering, construction management, construction science, or life science.

Required Experience and Knowledge

• 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).

Preferred

• 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).

Skills and Attributes

• 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

• Supervision required: Minimal; able to work independently.
• Supervisory responsibilities: None.

Physical Demands and Work Environment

• 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.

Why You'll Love Germfree

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

Pay and Financial Perks

• 401(k) with company match

Time Off and Leave

• 80 hours of paid holidays, including year-end shutdown
• Generous paid time off (PTO)

Equal Opportunity Employer

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.