Key skills
Communication
About this role
Role Overview
- Manage quality of ISO/IEC 17025 accredited calibration services for both lab and field operations.
- Ensure compliance with the Quality Management System, ISO/IEC 17025, and ISO 9001.
- Interface with Regulatory Agencies and Certification Bodies as required.
- Lead and support internal and external audits, including corrective actions and closure of findings.
- Develop, maintain, and improve SOPs, work instructions, and quality procedures covering lab and field activities.
- Perform technical analysis of non‑conformances from lab and field service; lead root cause analysis and CAPA.
- Develop and continuously improve calibration methods and procedures; establish best practices used in both lab and field environments.
- Ensure compliance with uncertainty budgets and maintain calculations and related documentation.
- Perform and analyze quality control checks.
- Review calibration certificates for accuracy and compliance with internal, customer, and accreditation requirements.
- Serve as a technical and metrology subject matter expert for lab and field service teams.
- Possibly conduct external presentations.
- Ensure lab and field equipment are suitable, functional, and properly calibrated; recommend upgrades or replacements.
- Administer the equipment records in the asset database (IndySoft).
- Develop and maintain training programs and competency requirements for lab technicians and field service engineers; maintain training records.
- Support customer inquiries and escalations related to service quality, calibration results, and compliance.
- Explore and oversee the implementation of new technologies and automation to improve calibration and service processes.
- Collaborate with EHS to develop and support EHS processes and safe work practices for field activities and lab operations.
- Collaborate closely with Operations, Engineering, Regulatory, Commercial, and Global/Regional Service teams.
Requirements
- Bachelor’s degree in engineering, science, or related technical field, or equivalent combination of education and experience.
- 3–5 years of related experience in calibration, metrology, quality engineering, or service quality.
- Preferably 2 years in a Pharma/Med‑Device or similarly regulated environment.
- Experience working within ISO/IEC 17025 and ISO 9001 quality systems.
- Hands‑on experience with accredited calibration laboratory work, including calibration methods and uncertainty budget calculations.
- Experience with non‑conformance management, root cause analysis, CAPA, and audits.
- Understanding of pharmaceutical requirements such as FDA, cGMP, USP, and MHRA.
- OSHA 10‑hour construction certification (required upon hire if not already held).
- Strong analytical and problem‑solving skills, with a continuous improvement mindset.
- Solid customer service orientation and ability to work directly with customers on quality topics.
- Fluency in spoken and written English.
- Excellent communication and technical writing skills.
- Interpersonal skills; comfortable collaborating across teams and locations.
- Valid US passport and ability to travel up to 20–25%, including some international travel.
Benefits
- health, dental, and vision insurance
- flexible spending accounts
- company paid life
- long and short term disability
- 401(K) plan with company match
- a variety of voluntary benefits programs
- fitness reimbursement
- Employee Assistance Programs
- tuition reimbursement
- holiday pay
- a generous paid time off plan