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Protingent
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Sr. Contract QA Engineer 4
100 San Lucar Court Sunnyvale, CA 94086 US
Posted: 02/02/2024
2024-02-02
2024-03-27
Employment Type:
Contract
Department: VMS
Job Number: 28328
Industry: MDEV - Medical Device
Job Description
Position Title: Sr. Contract QA Engineer 4
Position Description: Protingent Staffing has an exciting contract opportunity for Sr. Contract QA Engineer 4 with our client that is located in Sunnyvale, CA.
Job Responsibilities: 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.
• 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.
Job Qualifications:
• Engineering Bachelor’s degree - Preferably in science or healthcare fields.
• 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.
Nice To Have:
• 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.
Job Details:
• Contract: 6 months
• Pay Rate: $95 - 102 / hr
• Location: Sunnyvale, CA.
Benefits Package: Protingent offers competitive salaries, insurance plan options (HDHP plan or POS plan), education/certification reimbursement, pre-tax commuter benefits, Paid Time Off (PTO), and an administered 401k plan.
About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom, and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding, and exciting work opportunities for our candidates.
Position Description: Protingent Staffing has an exciting contract opportunity for Sr. Contract QA Engineer 4 with our client that is located in Sunnyvale, CA.
Job Responsibilities: 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.
• 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.
Job Qualifications:
• Engineering Bachelor’s degree - Preferably in science or healthcare fields.
• 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.
Nice To Have:
• 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.
Job Details:
• Contract: 6 months
• Pay Rate: $95 - 102 / hr
• Location: Sunnyvale, CA.
Benefits Package: Protingent offers competitive salaries, insurance plan options (HDHP plan or POS plan), education/certification reimbursement, pre-tax commuter benefits, Paid Time Off (PTO), and an administered 401k plan.
About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom, and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding, and exciting work opportunities for our candidates.
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