Quality Management System Lead
Description -We are seeking an experienced
Quality Management System (QMS) Lead to drive the development, implementation, and sustainability of a robust QMS. This role will support the product development lifecycle and future EUPIA/GMP manufacturing requirements across various technology platforms & work centers.
This is an
expert-level, highly visible role that requires deep systems expertise, strong cross-functional leadership, and the ability to influence priorities and behaviors to move the organization toward a documented, trained, and continuously improving system. This role will ensure that quality is embedded into everyday behaviors and processes and that the QMS is a practical and useful tool.
ResponsibilitiesQMS Development & Ownership- Own the overall QMS strategy and roadmap. Lead the development, rollout, and sustainment of QMS modules aligned to ISO 9001 and EUPIA/GMP requirements (e.g., CAPA, audits, change management, training, document control, records management, process control).
- Define the QMS framework and tiered documentation structure (policies, procedures, records), ensuring consistency and scalability across programs and organizations.
- Ensure QMS modules support both product development and manufacturing readiness.
- As required, develop and own QMS modules and systems before handing off to long-term owners.
- Work with management to identify and resolve resource needs associated with QMS.
- Serve as the subject matter expert on quality system standards and interpretations
- Align the QMS with adjacent organizations. Serve as a resource for other QMS efforts.
Implementation & Adoption- Partner with engineering, operations, and program leadership to embed QMS requirements into existing workflows.
- Support rollout of QMS practices into new areas beyond initial pilot groups.
- Reinforce behaviors through audits, metrics, and management reviews-not documentation alone.
- Ensure that the QMS efforts focus on usefulness and not check-the-box compliance.
Metrics, Reviews & Continuous Improvement- Define, track and integrate QMS-related metrics to existing meetings and review systems
- Lead & support QMS management reviews and executive sponsor updates.
- Identify systemic gaps and drive continuous improvement across processes and systems.
Required Qualifications and/or Experiences- Bachelor's degree in Engineering, Quality, Manufacturing, or related field (or equivalent experience).
- Previous experience building, implementing, and/or sustaining Quality Management Systems in an R&D and/or manufacturing environment.
- Working knowledge of ISO 9001; familiarity with EUPIA/GMP, GMP, or other regulated quality systems (medical, pharma, food, or similar).
- Experience with CAPA systems, internal audits, and document control.
- Understanding of product development processes, control plans and change management systems.
Preferred Experience and Skills- Ability to translate standards and regulatory language into clear, usable processes.
- Strong systems thinking - able to see interactions between systems, metrics, and behaviors.
- Strong understanding of Project Management Fundamentals, SPC & manufacturing processes.
- Excellent verbal and written communication skills, with the ability to influence at all levels of the organization without authority.
- Experienced with working with partners across all levels - including, but not limited to: operations, engineers, management, and Southeast Asia.
- Project and program leadership skills; able to drive progress across multiple parallel efforts.
- Comfortable working through ambiguity and evolving requirements
- Prior experience supporting audits & certification
- Experience with tiered documentation frameworks.
- Familiarity with document management system (e.g. DMS) and electronic change management tools (e.g., Windchill).
- Previous Product/Quality Engineering experiences
The pay range for this role is
$116,150 to
$182,400 USD annually with additional opportunities for pay in the form of bonus and/or equity (applies to United States of America candidates only). Pay varies by work location, job-related knowledge, skills, and experience.
Benefits:HP offers a comprehensive benefits package for this position, including:
- Health insurance
- Dental insurance
- Vision insurance
- Long term/short term disability insurance
- Employee assistance program
- Flexible spending account
- Life insurance
- Generous time off policies, including;
- 4-12 weeks fully paid parental leave based on tenure
- 11 paid holidays
- Additional flexible paid vacation and sick leave (US benefits overview)
The compensation and benefits information is accurate as of the date of this posting. The Company reserves the right to modify this information at any time, with or without notice, subject to applicable law.
Job -Engineering
Schedule -Full time
Shift -Shift 1, 0% premium (United States of America)
Travel -Relocation -
