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 expertlevel highly visible role that requires deep systems expertise strong crossfunctional 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.

Responsibilities

QMS 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 reviewsnot 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

• Bachelors 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$116150to$182400USD 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.

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Equal Opportunity Employer (EEO) -

HP Inc. provides equal employment opportunity to all employees and prospective employees without regard to race color religion sex national origin ancestry citizenship sexual orientation age disability or status as a protected veteran marital status familial status physical or mental disability medical condition pregnancy genetic predisposition or carrier status uniformed service status political affiliation or any other characteristic protected by applicable national federal state and local law(s).

Please be assured that you will not be subject to any adverse treatment if you choose to disclose the information requested. This information is provided voluntarily. The information obtained will be kept in strict confidence.

For more information review HPsEEO Policy or read about your rights as an applicant under the law here: Know Your Rights: Workplace Discrimination is Illegal