Logo
McCloskey Partners

Quality Engineer

McCloskey Partners, Telford, Pennsylvania, United States, 18969

Save Job

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.