Quality Systems Program Manager

Summary: Hiring a Quality Systems Program Manager with experience in Quality System Regulations and Project Management, focused on integrating and implementing QMS.

Requirements:

• Experience in Project Management

• Knowledge of Quality System Regulations (ISO 13485, 21 CFR 820)

• Experience in integration and/or implementation of QMS

• Bachelors degree with 7+ years of experience in Quality, Regulated industry and / or program management OR Advanced degree with 5+ years of experience in Quality, Regulated industry and / or program management

Responsibilities:

• Defining, managing, and implementing actions within the Companion Medical Integration Plan.

• Coordinating 3rd party consultancy review and management of outcomes (as required)

• Guiding the architecture, governance, and measurement of the program.

• Partnering with key stakeholders to define actions and plans to develop and maintain a high performing, scalable, compliant Quality System.

• Interpreting government regulations, agency guidelines, internal policies to assure compliance.

• Establishing and implementing meaningful metrics.

• Preparing quality reports and leadership communications.

• Planning, resourcing for multiple work streams; providing status for issues; identifying project risks; resolving issues

• Managing governance meetings; communicating risk appropriately

• Providing oversight for development/maintenance of quality programs/systems/processes/procedures ensuring compliance with policies conforming to established internal/external standards/guidelines

• Providing expertise/guidance interpreting policies/regulations assuring compliance

• Working directly with operating entities providing process analyses oversight enforcing requirements/meeting regulations.

 

 

 Pay: 40-60

 Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

Pay Details: $40.00 to $60.00 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 subject to federal contractor requirements and/or security clearance requirements.

Specializes in custom automation projects, they are a major player in the world of controls and robotic solutions around the world. My client will expand anyone resume and build them to be a top performing controls engineer.