Continuous Improvement Quality Coordinator

Amick Brown is seeking an experienced Continuous Improvement Quality Coordinator for our direct client.

Location: Sunnyvale, CA or Peachtree Corners, GA or Remote

Duration: 6 Months

Estimated pay range: $50 - $60 per hour per client contract and candidate skills, experience and work location.

Job Description

• This candidate will be advanced in Powerpoint and Excel. Be able to pull data, run reports, and present the data
• Strong complinance background
• Assist with CAPA coordinations
• Looking for Medical device experince
• Ensure that quality systems, products, and manufacturing processes comply with quality standards in accordance with international industry practices and regulations (e.g., ISO 13485, 21CFR820).
• Meet objectives, lead and provide CAPA coordination data analytics and provide clear, professional updates to leadership.
• S/he will partner with CAPA CIQE team and subject matter experts on various CAPA activities.
• S/he will help ensure CAPA logs are accurate, CRB meetings are scheduled/coordinated, there is timely CAPA initiation and execution, and review of CAPAs occurs within a closed-loop quality management system.
  
  

Essential Job Duties

• Support and comply with Company and Site’s Health, Safety, and Environmental programs and requirements, including:
• Use of personal protective equipment (PPE) as applicable.
• Use devices, accessories, tools, and equipment according to the process, verifying that they are in good condition for use and reporting those that are in poor condition for repair.
• Communicates unsafe acts or conditions to their superiors.
• Participates in the Health, Safety, and Environment courses established.
• Maintains order and cleanliness in the workstation (5S) under responsibility.
• Complies with health regulatory and International Standard (ISO13485) requirements, Company and site policies, operating procedures, processes, and task assignments.
• Participate in and help coordinate CAPA projects, assuring compliance, quality, and timeliness of records.
• Communicate confidently and effectively with all levels of management, peers, and key stakeholders, including timely escalation of quality issues.
• Process requests, ensuring subject matter experts and action item owners are assigned and provide timely responses in alignment with quality goals.
• Execute and provide on-time completion of Quality Engineering or Quality Plan deliverables.
• Schedules and leads meetings and communications for CAPA updates, information, and concerns.
• Responsible for assisting with metrics and reporting in accordance with established procedures.
  
  

Required Skills And Experience

• Quality Engineer: Systems, Assurance, or Quality Control – Minimum 4 Years experience
• Have worked in a regulated manufacturing industry: Medical devices, Pharmaceuticals, Aerospace, Automobile, Food, etc. - Minimum 4 Years
• Previous CAPA and/or engineering experience
• Detailed knowledge of Quality System Regulations (21CFR820) and ISO 13485. - Minimum 3 Years
• Ability to work in a highly matrixed and geographically diverse business environment
• Quality/Compliance focus and attention to detail
• Advanced to Expert computer skills (Primary focus- Microsoft Outlook, PowerPoint, and Excel)
• Demonstrated impactful project management skills, including the ability to coordinate multi-departmental project teams in a timely and effective manner
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment
• Ability to leverage and/or engage others to accomplish projects
• Strong verbal/written communication skills with ability to communicate effectively at multiple organizational levels
• Multi-tasks, prioritizes, and meets deadlines in a timely manner
• Strong interpersonal, organizational, and follow-up skills
  
  

Required Education And Training

• Engineering Bachelor’s degree - Preferably in science or healthcare fields.
  
  

Working Conditions

• Desk and meeting rooms (as applicable)
  
  

Preferred Skills And Experience

• ASQ certification: CQE, CQA
• Knowledge of Process improvement tools and methodologies (Lean, Six Sigma) is preferred.
• CAPA performance or coordination (including data analysis and metric reporting)
• Management Review
• Project Management experience
• Experience working in a broader enterprise/cross-division business unit model
  
  

Amick Brown is an Information Technology consulting company specializing in ERP, Data Analytics, Information Security, Application Development, Networking, and Cloud Computing. The company was founded in 2010 and is headquartered in San Ramon, California.

Regular full-time employees are eligible for the following Amick Brown provided benefits:

• Health
• Vision
• Dental
• 401k with company match
• Paid time off.
• Sick Leave
• Long -Term Disability
• Life Insurance
• Wellness & Discount Programs