Sr Quality Systems Specialist

Summary/Purpose

Includes ownership of site’s internal audit program and quality system documentation infrastructure, ensuring sustained IATF 16949 certification, customer specific requirement compliance, and audit readiness.  This role will lead internal audits, document control, management of change, and quality management review support, serving as a key resource. 

Essential Duties and Accountabilities:

To perform this job successfully, an individual must be able to perform the essential duties satisfactorily.

• Own and lead the internal audit program: build and maintain the annual audit schedule, select and train internal auditors, conduct audits directly, and ensure audit coverage meets IATF 16949 requirements across all process areas and shifts.
• Lead audit readiness and coordination for IATF 16949 certification, surveillance, and customer audits - including preparation, on-site audit support, nonconformance response coordination, and closure verification of corrective actions.
• Drive root cause analysis and effectiveness verification for internal and external audit findings; escalate systemic or recurring issues to plant leadership with data to support corrective direction.
• Own controlled quality system documentation: procedures, work instructions, forms, records, revision history, approval workflows, access control, and retention per IATF 16949 requirements.
• Ensure current approved revisions are available at point of use; remove or secure obsolete documents from unintended use on the floor.
• Lead management of change (MOC) - manufacturing process changes, inspection method changes, control plans, PFMEAs, and related plant quality documentation - including risk review, cross-functional sign-off coordination, and implementation verification. Recommends disposition and release readiness; final sign-off authority rests with the Plant Manager, Quality Manager or Engineering Manager.
• Track 8D corrective action status and closure as part of the CAPA tracking system; flag overdue or stalled 8Ds with audit/certification exposure to plant leadership.
• Lead Quality Management Review (QMR) preparation per IATF 16949 to collect audit results, CAPA/8D status, system performance trends, and recurring nonconformance data; prepare summary materials and take/distribute meeting minutes with assigned action items.
• Maintain QMS databases/tracking tools for audits, CAPA, document control, and related compliance records; proactively flag data integrity gaps and overdue items before they surface in external audits.
• Act as a key point of contact for external registrars and customer auditors during certification and surveillance activity.
• Partner with Quality, Engineering, Production, Maintenance, and Production Control to ensure quality system requirements translate into day-to-day shop floor practice, not just paper compliance
• Other duties as assigned by management

Supervisory Responsibilities:

• This position does not have any supervisory responsibilities.

Job Knowledge, Skills and Abilities:

The requirements listed below are representative of the knowledge, skill and/or ability required.

• Strong knowledge of IATF 16949 requirements, including clause structure relevant to audit, documentation, change control and management review
• Strong organizational skills, self-directed with focus on achieving target/goals to a plan
• Proficient with MS Office applications and QMS or document management platforms
• Highly motivated, high energy with a positive outlook
• Excellent oral and written communications skills at all levels
• Flexible working hours, overtime and travel as required

Education and Experience:

• Associate’s degree in a related field is preferred or equivalent relevant work experience in a manufacturing environment
• Direct experience in an IATF 16949-certified manufacturing plant, including direct internal audit experience
• IATF 16949 or ISO 9001 internal auditor certification required; lead auditor training is strongly preferred
• Demonstrated experience planning and executing an internal audit program
• Prior experience with document control systems, CAPA tracking and controlled quality records
• Prior experience leading cross-functional process or documentation changes in a manufacturing environment
• Familiarity with AIAG core tools (i.e., APQP, PPAP, PFMEA, Control Plan, MSA, SPC, 8D problem solving)
• Experience with customer specific requirements (CSRs) and external registrar / customer led audits

Work Environment/Physical Demands:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Work shift as assigned and overtime is required, as needed.
• Will be required to do the following throughout the shift: standing, bending, pushing, pulling, reaching above and below shoulders, moving left to right repetitively, grasping, and fine finger dexterity. 
• May be required to lift during shift up to 40 lbs.
• Specific vision abilities required with this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
• The performance of this position requires exposure to manufacturing areas which require the use of personal protective equipment such as steel toed shoes, safety glasses with side shields.