Director of Quality

Krieger Scientific; Philadelphia (Philadelphia County); On-site; USD 120,000 - 180,000; Full time

Job summary

Krieger Scientific, a specialist in calibration, metrology and validation services, seeks a hands-on Quality Leader to own and enhance the QMS across ISO 9001 and ISO/IEC 17025. The role focuses on certification readiness and ongoing improvement within our laboratory operations.

Based in the Doylestown, PA or Raleigh, NC area with on-site work and travel as needed, you will lead audits, maintain document control, manage CAPA and training, and partner with technical staff to sustain traceability

Qualifications

• Direct, hands-on experience owning or maintaining a QMS in a calibration, metrology, or ISO/IEC 17025-accredited testing laboratory.
• Practical working knowledge of ISO/IEC 17025 and ISO 9001, including audits, assessment preparation, findings, and ongoing compliance.
• Experience with calibration quality records, traceability, document control, CAPA, and laboratory competency requirements.
• Ability to independently manage day-to-day quality work and partner effectively with technical staff.
• Clear written communication, sound judgment, and a continuous-improvement mindset.
• Experience with A2LA or another recognized accreditation body is valuable; formal lead-auditor or metrology training is a plus.

Responsibilities

• Take ownership of the existing ISO 9001 and ISO/IEC 17025 QMS, assess remaining gaps, and drive readiness through certification and accreditation assessments.
• Maintain controlled documents, calibration procedures, SOPs, forms, revisions, approvals, retention, and quality records.
• Plan and conduct internal audits; coordinate external certification and accreditation assessments; respond to findings and verify corrective action effectiveness.
• Manage nonconformances, root-cause investigations, CAPA, risk assessments, management reviews, and continual improvement.
• Maintain quality oversight of calibration laboratory processes, including traceability, measurement uncertainty, proficiency testing or interlaboratory comparisons, and technical records in partnership with laboratory personnel.
• Own the quality training program, including QMS, procedures, safety, competency records, and required refresher training.
• Monitor quality metrics and communicate compliance status, risks, and improvement priorities directly to the President and CEO.
• Support quality consistency as Krieger expands its laboratory operations and service locations.

Skills

QMS ownership

Audits

Document control

CAPA

Quality management

Communication

Job description

Krieger Scientific| Reports to: President & CEO |Location: Doylestown, PA or Raleigh, NC area

About Krieger Scientific

Krieger Scientific provides calibration, engineering, commissioning, qualification and validation, asset management, quality and compliance consulting, and technical staffing services to pharmaceutical, biotechnology, and medical device organizations.

The Opportunity

We are looking for a hands-on quality leader from the metrology and calibration industry to take ownership of an established Quality Management System (QMS). The immediate priority is to guide the existing system through its remaining ISO 9001 certification and ISO/IEC 17025 accreditation requirements, then maintain and continuously improve it as our laboratory operations grow. This is an operational quality role, not a ground-up QMS design assignment or a corporate pharmaceutical QA position.

Responsibilities

• Take ownership of the existing ISO 9001 and ISO/IEC 17025 QMS, assess remaining gaps, and drive readiness through certification and accreditation assessments.
• Maintain controlled documents, calibration procedures, SOPs, forms, revisions, approvals, retention, and quality records.
• Plan and conduct internal audits; coordinate external certification and accreditation assessments; respond to findings and verify corrective action effectiveness.
• Manage nonconformances, root-cause investigations, CAPA, risk assessments, management reviews, and continual improvement.
• Maintain quality oversight of calibration laboratory processes, including traceability, measurement uncertainty, proficiency testing or interlaboratory comparisons, and technical records in partnership with laboratory personnel.
• Own the quality training program, including QMS, procedures, safety, competency records, and required refresher training.
• Monitor quality metrics and communicate compliance status, risks, and improvement priorities directly to the President and CEO.
• Support quality consistency as Krieger expands its laboratory operations and service locations.

Qualifications

• Direct, hands-on experience owning or maintaining a QMS in a calibration, metrology, or ISO/IEC 17025-accredited testing laboratory.
• Practical working knowledge of ISO/IEC 17025 and ISO 9001, including audits, assessment preparation, findings, and ongoing compliance.
• Experience with calibration quality records, traceability, document control, CAPA, and laboratory competency requirements.
• Ability to independently manage day-to-day quality work and partner effectively with technical staff.
• Clear written communication, sound judgment, and a continuous-improvement mindset.
• Experience with A2LA or another recognized accreditation body is valuable; formal lead-auditor or metrology training is a plus.

Work Arrangement

Candidates should be based within practical reach of Doylestown, Pennsylvania, or the Raleigh, North Carolina area, with on-site presence and travel as required for laboratory operations and assessments.

Krieger Scientific is an equal opportunity employer. Employment decisions are based on qualifications, merit, and business needs without regard to protected status under applicable law.