QA Documentation Manager

OSI Systems, Inc.; Massachusetts; On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Quality Assurance Documentation Manager to enhance and standardize QA processes across its global operations. This pivotal role involves managing documentation, ensuring compliance with regulatory standards, and fostering collaboration among teams. The ideal candidate will possess extensive experience in Quality Assurance within complex manufacturing environments, showcasing strong analytical and problem-solving skills. Join a forward-thinking organization committed to innovation and excellence in security solutions, where your expertise will drive significant improvements and ensure quality across all operations.

Qualifications

• 10+ years in Quality Assurance in complex manufacturing industries required.
• Experience in managerial roles and multinational organizations is essential.

Responsibilities

• Develop and standardize Quality Assurance documentation across sites.
• Ensure compliance with regulatory bodies and ISO requirements.
• Manage documentation control and communication with relevant teams.

Skills

Quality Assurance

Analytical Skills

Problem-Solving

Communication Skills

Process Improvement

Documentation Management

Education

Bachelor's Degree in Engineering or Business

Master's Degree

Tools

ISO 9001

AS9100

Six Sigma

Job description

Overview

Rapiscan, an OSI Systems Company is seeking a QA Documentation Manager, based out of Billerica, MA.

Rapiscan is a leading supplier of end-to-end security inspection solutions, utilizing multiple technologies and advanced threat identification algorithms based on X-ray and high-speed computed tomography imaging, ion mobility spectrometry, radiation detection, and optical inspection technologies. Our broad portfolio of products, services, and solutions helps customers in ports, borders, aviation, military, law enforcement, critical infrastructure, event security markets to solve complex security needs, including combatting terrorism, drug and weapon smuggling, and trade fraud. With our leading detection technology and vast industry knowledge, we meet demanding security requirements while offering customers outstanding value for their security screening and inspection operations. We have highly experienced technical, program management, and service teams to ensure customers receive a best-in-class experience throughout every phase of their project—from planning to deployment to post-installation support.

Manage Rapiscan Systems Quality Assurance documentation through alignment of documentation processes and procedures, significantly reducing the number of duplicate Quality Assurance documents and localized interpretations. Identification and agreement of standardized best practices for Quality Assurance.

Reporting to the Director of Quality Assurance, the Quality Assurance Documentation Manager will play a pivotal role in aligning, standardizing and identifying QA best practices across Rapiscan Systems global manufacturing sites delivering common process and procedure documentation that supports a globally integrated Quality Management System.

The position requires excellent knowledge of operational procedures, Quality Assurance methodologies, metrics and functional systems. This role requires a detailed, process driven and analytical thinker with a strong background in Quality Assurance, QMS, Process and documentation writing.

Responsibilities

• Develop, own and implement a plan to systematically align/combine/standardize the key Quality Assurance documents across Rapiscan Systems sites.
• Reduce/eliminate ambiguity and misinterpretation within the documentation.
• Identify, agree and encompass Quality Assurance ‘Best Practices’ within common documentation.
• Ensure where required processes and procedures are compliant with regulatory bodies.
• Ensure product specific requirements are considered and clearly documented.
• Collation of Quality Assurance documentation for ease of identification and access.
• Manage documentation control, including versions, naming conventions and general documentation storage ‘housekeeping’ (archiving).
• Ensure all aspects of Quality Assurance documentation management is in alignment with current ISO requirements.
• Work with relevant teams to ensure agreement, understanding and implementation of the revised Quality Assurance documented processes and procedures.
• Deliver regular (as agreed with the Director of QA) communication status reports against plan.

Critical Success Factors

The following critical success factors represent those most critical in year one to ensure success:

• Establish strong, trust-based working relationships with the leadership team, peers, and their own team.
• Prioritization of documentation to be standardized.
• Agreed best practices for Quality Assurance.
• A framework for QA documentation storage and management.
• Obsolete versions archived.
• Naming conventions agreed and implemented.
• Demonstrate behaviour consistent with the company’s Code of Ethics and Conduct.
• It is the responsibility of every employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem.
• Duties may be modified or assigned at any time to meet the needs of the business.
• Uphold the company’s core values of Integrity, Innovation, Accountability, and Teamwork.

Qualifications

• A bachelor’s degree in engineering, business, or another relevant area required. Master’s degree preferred.
• Minimum of 10 years of progressive experience in Quality Assurance functions in complex manufacturing industries with significant regulatory exposure required.
• 5+ years of professional experience in a managerial role required.
• Demonstrated experience in globally dispersed multinational organizations.
• In-depth knowledge of quality standards, product regulations, and certification processes such as AS9100, ISO 9001, TSA, ECAC, EASA, etc.
• Proven experience in leading and driving continuous improvement initiatives, using quality tools and techniques such as Six Sigma, 8D, root cause analysis, etc. AS9145 APQP/PAPP and Lean certification highly preferred.
• Strong analytical and problem-solving skills, with a data-driven approach to decision-making.
• Excellent communication and people skills, with the ability to build strong relationships with internal and external stakeholders.
• Demonstrated ability to collaborate with cross-functional teams and communicate technical information to non-technical stakeholders.
• Must be able to work across time zones – North America, Europe, Middle East and South East Asia.