Quality Engineer

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.