Quality Systems Specialist

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

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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 Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San 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.