Quality Manager

POSITION TITLE:

Quality Manager

This role requires U.S. work authorization and does not provide visa sponsorship

FUNCTION:

The Quality Manager will oversee and manage the quality assurance and control processes within the organization. This role involves developing, implementing, and maintaining quality standards, procedures, and systems to ensure product and process integrity. The Quality Manager will lead continuous improvement initiatives, manage quality audits, and collaborate with various departments to resolve quality issues and enhance overall product quality.

ESSENTIAL DUTIES AND KEY RESPONSIBILITIES:

• Develop and implement quality assurance policies, procedures, and standards.
• Lead and manage quality assurance and control activities, including product safety inspections, audits, sampling inspections, and process validations.
• Oversee the analysis of quantitative and qualitative data to identify trends and areas for improvement.
• Train and mentor quality assurance staff, ensuring adherence to quality standards and procedures.
• Collaborate with cross-functional teams to identify and resolve quality issues, implement process improvements, and achieve cost savings.
• Conduct internal and external audits to ensure compliance with regulatory and industry standards.
• Investigate customer complaints and work with department managers to develop corrective and preventive actions.
• Prepare and present quality documentation and reports, including trend analysis, corrective actions, and re-validations.
• Manage the quality control laboratory and ensure accurate testing and measurement of products and materials.
• Maintain and improve product quality by completing product, company, system, compliance, and surveillance audits.
• Validate quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality procedures.
• Participate in and lead projects resulting in streamlining processes, improvements, and cost savings.
• Direct and organize work priorities for quality technicians and assist in resolving team challenges to achieve daily goals.
• Establish and maintain safety operations by adhering to procedures and policies.
• Perform other related duties as required.

REQUIREMENTS:

• Strong knowledge of quality assurance principles, practices, and standards (e.g., ISO 9001, GMP).
• Proficiency in statistical analysis, SPC, and quality management systems.
• Excellent communication, facilitation, and coaching skills.
• Ability to work well under pressure and in a fast-paced environment.
• Strong problem-solving and decision-making abilities.
• Proficiency in MS Office and ERP systems.
• Lean or Six Sigma certification is a plus.
• ASQ-CQE certification is a plus.
• Bilingual English/Spanish is a plus.

SUPERVISORY RESPONSIBILITIES:

Oversees quality assurance staff, including quality control technicians and quality assurance supervisors.

EDUCATION/EXPERIENCE:

• Bachelor's degree in chemistry, biochemistry, or a related field.
• Minimum of 3 years of experience in quality management within a manufacturing environment.
• Hands-on experience in quality control and assurance processes.
• Knowledge of GMP, ISO 9001, and other relevant quality standards.

CERTIFICATES:

None required, but certifications such as Lean, Six Sigma, or ASQ-CQE are a plus.

LANGUAGE SKILLS:

• Excellent communication proficiency with oral and written skills.
• Ability to read, analyze, and interpret technical procedures, governmental regulations, and business periodicals.
• Ability to write reports and procedure manuals and effectively present information to management.

MATHEMATICAL SKILLS:

• Strong math skills, including algebra and statistics.
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

REASONING ABILITY:

• Strong independent decision-making abilities.
• Ethical conduct and excellent collaboration skills.
• Ability to solve critical problems and devise new methods or concepts.

PHYSICAL DEMANDS:

• This position is mostly sedentary and requires little repetitive hand movements.
• May require some standing, walking, bending, and lifting throughout the workday.
• Specific vision abilities required include close vision and the ability to work in front of a computer monitor for extended periods.

WORK ENVIRONMENT:

• Professional office environment.
• Manufacturing plant is not environmentally controlled, with changes in humidity and temperature throughout the year.
• Conditions are maintained within OSHA standards, monitored by the Safety Committee.