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Staff Quality Engineer- Pharma and Diagnostics

Iconma

Marlborough, MA

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JOB DETAILS
SKILLS
American Society for Quality (ASQ), Analysis Skills, Best Practices, Biotech and Pharmaceutical, Business Processes, Code of Federal Regulations, Communication Skills, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Design Verification, Detail Oriented, Document Management, Documentation, Documentation Review, Ergonomics, External Audit, FDA (Food and Drug Administration), Fax Machines, File Maintenance, Hazard Analysis, Health Plan, ISO (International Organization for Standardization), Industry Standards, Industry/Trade Analysis, Internal Audit, International Electro-Technical Commission (IEC), Interpersonal Skills, Leadership, Maintain Compliance, Matrix Management, Medical Equipment, Medical Research, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Office Equipment, Organizational Skills, Presentation/Verbal Skills, Printers, Problem Solving Skills, Process Improvement, Product Design, Product Development, Product Lifecycle, Product Safety, Quality Engineering, Quality Management, Quality Metrics, Quality Monitoring, Regulations, Regulatory Requirements, Regulatory Submissions, Risk Analysis, Risk Management, Surveillance, Systems Maintenance, Team Lead/Manager, Trend Analysis, Validation Plan, Validation Testing, Vendor/Supplier Selection, Willing to Travel, Writing Skills
LOCATION
Marlborough, MA
POSTED
Today
Our Client, a Medical Research company, is looking for a Staff Quality Engineer- Pharma and Diagnostics for their Marlborough MA/ Hybrid location.
 
Responsibilities:
  • Develop, implement and maintain quality systems and processes in compliance with FDA CFR Part 820, ISO 13485, IVDR 2017/746, ISO 14971 and other regulations, as appropriate, for IVD products
  • Conduct hazard analysis and risk assessments for IVD products according to ISO14971 throughout the IVD product lifecycle
  • Lead internal and external audits, including preparation, execution, and follow-up to ensure adherence to quality and client standards and regulatory requirements
  • Oversee corrective and preventive action (CAPA) processes, non-conformance investigations and deviations to resolve quality issues
  • Collaborate with cross-functional product development teams to integrate quality requirements into product design, verification and validation activities according to Design Controls
  • Review and approve design control documentation including design inputs, design outputs, verification/validation protocols and reports, and risk management documentation.
  • Assess and qualify new suppliers in product development and throughout the product lifecycle.
  • Establish and maintain Design History File for IVD products
  • Establish, monitor and analyze quality metrics, trends and performance data to identify areas of improvement
  • Support regulatory submissions and activities for IVD product approvals
  • Support complaints process (review, process, investigate, trend quality data, etc.) and post-market incident activities.
  • Support post-market incident activities
  • Manage post-market incident activities (field action, MDRs, EU incident decision/reporting, field failure trending).
  • Maintain knowledge of laboratory regulatory requirements, including accrediting bodies, federal, state, and local requirements as well as Client policies.
  • Drive continuous improvement initiatives in design control and risk management processes, leveraging industry best practices, lessons learned, and feedback from audits and post-market surveillance data
  • Stay current with evolving regulatory requirements, standards, and industry trends
  • Proactively update internal processes, policies and procedures, and training materials as needed
  • Drive continuous improvement initiatives in design control and risk management processes, leveraging industry best practices, lessons learned, and feedback from audits and post-market surveillance data
  • Stay current with evolving regulatory requirements, standards, and industry trends
  • Proactively update internal processes, policies and procedures, and training materials as needed
  • Follow corporate policies and procedures
  • Perform other duties as assigned.
 
Requirements:
  • Required Work Experience:
  • 8+ years of experience in Medical Devices design and development with a strong focus on design control and risk management
  • Preferred Work Experience:
  • Experience in working effectively in an FDA-regulated environment
  • Experience working with IVD products
  • Analytical mindset with attention to detail and a commitment to integrity, product safety, and Quality
  • Demonstrated Experience applying medical device regulations (e.g.IEC 62304, FDA 21 CFR Part 803, 21 CFR Part 806, 21 CFR Part 820, ISO 13485, ISO 14971, IVDR, CAP, and CLIA).
  • Knowledge:
  • Experience with quality management system development, Design Controls, and risk management
  • Skills:
  • Communication (verbal and written), ability to build and manage an effective team, being able to influence others and drive for results, effective presentation skills, problem solving
  • Competencies:
  • Demonstrate ability to influence and create change
  • Strong interpersonal communication skills
  • Demonstrate strong writing and composition skills
  • Demonstrate success in motivating team members to reach objectives
  • Business Process Skills
  • Able to effect Quality Improvement through problem solving skills and knowledge of quality tools
  • Able to lead and drive change
  • Organization skills
  • Project and team management skills
  • Analytical and problem-solving skills
  • Proficient in Microsoft Word, Excel, and Powerpoint
  • Able to function in a matrix organization
  • Flexibility to meet continuously changing priorities and challenges
  • Requires ability to understand, interpret and apply quality and regulatory requirements.
  • Work Environment:
  • Prolonged sitting at a desk (i.e., operating a computer, telephone use, document review)
  • Walking or standing within the office area to operate other office equipment (i.e. printer / fax) or within the laboratory
  • Required to wear PPE as appropriate when visiting testing locations
  • Must frequently respond to text/email communications and will be required to be aware of ergonomic principles
  • May be required to travel by airplane /train or drive long distances
  • Ability to follow verbal or written instructions and use effective verbal and written communication
  • Education
  • Bachelor’s Degree (Required)
  • License/Certifications
  • ASQ Certification preferred
  • Regulatory Affairs Certification (RAC) preferred
  • Experience in Medical Devices design and development with a strong focus on design control and risk management is preferred
  • Please ensure the team understands they need to send us individuals who have worked within Quality/Regulatory Affairs function and understand/have experience as discussed.
 
Why Should You Apply?
  • Health Benefits
  • Referral Program
  • Excellent growth and advancement opportunities

About the Company

I

Iconma

ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.

  • Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
  • Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
  • Founded in 2000
  • 2000+ Employees

The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Management Consulting Services
EMPLOYEE BENEFITS
401K, Employee Referral Program, Life Insurance
FOUNDED
2000
WEBSITE
https://www.iconma.com/

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