Senior Continuous Improvement Quality Engineer
Location
Sunnyvale, CA | United States
Job description
Amick Brown is seeking an experienced Senior Continuous Improvement Quality Engineer for our direct client.
Location: Sunnyvale, CA or Peachtree Corners, GA
Duration: 6 Months
Estimated pay range: $80 - $100 per hour per client contract and candidate skills, experience and work location.
Job Description
Primary Function of the Position
- Ensure that quality systems, products, and manufacturing processes comply with quality standards by supporting robust root cause analyses, CAPA independent reviews, and remediation activities (as applicable) in accordance with international industry practices and regulations (e.g., ISO 13485, 21CFR820).
- Meet objectives, provide support and expertise in corrective and preventive action (CAPA) process and system.
- S/he will partner with CAPA CIQE team and subject matter experts on various CAPA activities.
- S/he will ensure robust investigation of product quality and compliance issues 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.
- Complies with health regulatory and International Standard (ISO13485) requirements, Company and site policies, operating procedures, processes, and task assignments.
- Participate in review and completion of 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.
- Collaborate with cross-functional teams using various methodologies (e.g., Six Sigma root cause analysis/problem-solving skills).
- Provide CAPA subject matter expertise to independently review investigations and other quality events as applicable
- 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.
Required Skills and Experience
- Quality Engineer: Systems, Assurance, or Quality Control Minimum 10 Years experience
- Have worked in a regulated manufacturing industry: Medical devices, Pharmaceuticals, Biotechnology, etc. - Minimum 10 Years
- Previous CAPA and/or engineering experience and demonstrated use of quality tools/methodologies. - Minimum 10 Years of work experience
- Detailed knowledge of Quality System Regulations (21CFR820) and ISO 13485. - Minimum 8 Years
- Ability to work in a highly matrixed and geographically diverse business environment
- Quality/Compliance focus and attention to detail
- Critical thinking skills for analyzing risk, use of root cause analysis tools, and technical aptitude to collect and analyze data and details surrounding quality events
- Expertise in cGMP and CAPA documentation
- Computer skills (advanced Microsoft Office Package and statistical/data analysis and report writing skills)
- 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
- Passionate about making products and processes better
Required Education and Training
- Engineering Bachelor's degree - Preferably in science or healthcare fields.
Working Conditions
Preferred Skills and Experience
- ASQ certification: CQE, CQA
- Knowledge of Process improvement tools and methodologies (Lean, Six Sigma) is preferred. Green or Black Belt Certification in Lean or Six Sigma is a plus
- CAPA Review and Approval
- Remediation 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
Job tags
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