Quality Manager

Position Summary: The Quality Manager plays a key leadership role within the organization, ensuring that all company operations and output align with ISO 9001:2015 standards and internal quality objectives. This position requires hands-on quality inspection, audit coordination, cross-functional collaboration, and the development and enforcement of quality control procedures. The ideal candidate is a proactive and organized individual with a strong mechanical background, exceptional attention to detail, and proven leadership experience in a manufacturing or machine shop environment.

Principal Duties and Responsibilities:
 

• Lead the Quality Department, including managing one Inspector and stepping in for inspections during peak times, staff absences, or vacations.
• Ensure compliance with ISO 9001:2015 standards. Manage and conduct internal and external audits from start to finish.
• Collaborate with Production to establish, maintain, and improve documented workflows and procedures for operational efficiency.
• Conduct inspections of components and calibrate field-use tool kits used in pharmaceutical applications to ensure accuracy and reliability.
• Partner with Sales, Engineering, Service, and Production teams to integrate quality at every level of the organization.
• Draft, revise, and maintain Standard Operating Procedures (SOPs) and departmental flowcharts to enhance documentation and compliance.
• Manage and mentor the department’s Inspector, aligning team goals with company-wide quality objectives.
• Be available for extended hours during audits or production surges—this position requires a flexible approach to scheduling.

Skills and Experience:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 

• Comprehensive knowledge of ISO 9001:2015 requirements and audit processes.
• Hands-on experience in a machine shop or similar manufacturing environment is essential.
• Skilled in planning and executing audits, as well as maintaining audit readiness year-round.
• Proficient in writing and updating SOPs, process maps, and related documentation.
• Strong Microsoft Office skills, especially in Excel, Word, and PowerPoint.
• Degree or technical training in Mechanical Engineering preferred.
• Proven experience in managing and developing team members within a quality-driven department.

The department consists of the Quality Manager and one Inspector, requiring the Manager to be actively involved in both management and inspection tasks. This is not a traditional desk job—our ideal candidate must be comfortable rolling up their sleeves and stepping in when needed.

Key Responsibilities:

1. Hands-On Quality Management: Lead the Quality Department, which includes managing one Inspector and stepping in to perform inspections during peak workloads, vacations, or absences.

2. ISO 9001:2015 Compliance: Ensure the company meets all ISO 9001:2015 standards, including handling ISO audits from inception to completion and conducting internal and external audits.

3. Process Development & Improvement: Assist the production team in setting up and maintaining documented processes to improve workflow and efficiency.

4. Inspection & Calibration: Perform detailed inspections of products and calibrate portable tool kits used in pharmaceutical service applications.

5. Cross-Department Collaboration: Work closely with Sales, Engineering, Service, and Production teams to ensure quality is integrated throughout all processes.

6. SOPs & Flow Charts: Create and update Standard Operating Procedures (SOPs) and departmental flowcharts to enhance efficiency and compliance.

7. Employee Supervision: Manage and mentor the Inspector, ensuring alignment with company goals and quality standards.

8. Flexible Schedule & Overtime: This is not a 9-to-5 job—extra hours may be required to meet business needs, especially during audits and peak production times.

Qualifications & Skills:

1. ISO 9001:2015 Expertise – In-depth knowledge of requirements, implementation, and audits.

2. Hands-On Mechanical Skills – Experience in a machine shop environment is required.

3. Audit Management – Ability to lead internal and external audits and ensure regulatory compliance.

4. Process Documentation – Skilled in writing and maintaining SOPs and process flow charts.

5. Technical Proficiency – Must be proficient in Excel, Word, and PowerPoint.

6. Mechanical Engineering Background – A degree or relevant training in Mechanical Engineering is helpful.

7. Leadership Abilities – Experience managing employees and fostering a team-oriented environment.