Seeking Senior Quality Systems Specialist to lead large-scale QMS initiatives in regulated medical device or pharmaceutical environments.

Requirements

Bachelor’s degree (Engineering, Life Sciences, or related field)

3+ years in Quality Systems within medical device, pharmaceutical, or regulated environment

Working knowledge of FDA 21 CFR 820, 21 CFR Part 11, and ISO 13485

Experience executing quality projects with defined scope, schedule, and budget

Proficiency in risk management and mitigation methods (e.g., FMEA, fault tree)

Experience with Product Lifecycle Management (PLM) systems (e.g., Agile, Windchill)

Competence with CAPA, change control, document control, training, and audit readiness

Preferred Skills

Lean Six Sigma certification or demonstrated use of LSS tools

Experience supporting integrations during mergers and acquisitions

Experience with software validation/CSV and electronic quality systems (eQMS)

Familiarity with supplier quality processes and purchasing controls

Experience facilitating cross-functional quality reviews and management reviews

Responsibilities

Lead planning and execution of large-scale QMS projects and continuous improvement initiatives

Maintain compliance to FDA 21 CFR 820/Part 11 and ISO 13485 across quality subsystems

Drive CAPA lifecycle activities, track effectiveness checks, and ensure timely closure

Manage change control processes, document control, and training program effectiveness

Conduct risk assessments (e.g., process FMEA) and implement risk mitigation strategies

Support internal and external audits; coordinate responses, remediation plans, and verification of effectiveness

Administer and optimize PLM/eQMS workflows and data integrity controls

Generate metrics and dashboards for management review and regulatory inspection readiness

Pay Details: $42.00 to $56.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
The California Fair Chance ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.