Quality Management Systems (QMS) Lead

OSI Systems, Inc • Billerica, MA

6d

About The Position

Rapiscan, an OSI Systems Company is seeking a Quality Management Systems (QMS) Lead, based out of Billerica, MA.
Rapiscan Systems, an OSI Systems, Inc. company, designs, manufactures and markets security and inspection systems worldwide. Our products are used to inspect baggage, cargo, people, vehicles and other objects for weapons, explosives, drugs and other contraband. Rapiscan Systems security and inspection devices can be found in a wide range of locations such as airports, border crossings, railway stations, seaports and terminals, government and military installations, and nuclear facilities.
At the direction of the Director of Quality Systems, lead/support all aspects of Rapiscan Systems’ Quality Management System (QMS), including:
Support of the creation, clarity, and alignment of procedures and work instructions
Execution of the documentation control process
Lead/assist in internal and external audit activities
Collection and presentation of QMS metrics
The role aims to support a robust QMS and Environmental, Health and Safety (EHS) procedures that are ISO9001 and ISO14001 compliant and drive business performance through clearly documented departmental roles, responsibilities, and processes.
One aspect of the role is to significantly reduce the number of duplicate QMS documents across the global company, while identifying and closing process gaps.
Reporting to the Director of Quality Systems, the Quality Management Systems Lead will play a pivotal role in identifying, aligning, standardizing and creating QMS best practices across Rapiscan Systems global manufacturing sites.
The position requires excellent knowledge of Quality Management Systems, operational procedures, quality methodologies, metrics, and business functions and interactions.
This role requires a detailed, process driven and analytical thinker with a strong background in Quality, QMS, Process and Document Control.

Requirements

• Bachelor’s degree in engineering, business, or another relevant area required. Master’s degree preferred.
• Minimum of 8 years of progressive experience in Quality functions in complex manufacturing industries with significant regulatory exposure.
• 2+ years of professional experience in a managerial role preferred
• In-depth knowledge of ISO9001
• In-depth knowledge of ISO14001 is desirable
• Working knowledge of additional quality standards, product regulations, and certification processes such as AS9100, TSA, ECAC, EASA, etc
• ISO9001 auditor experience, with Lead Auditor experience preferred
• In-depth knowledge of PLM systems and document control methodologies
• Demonstrated experience in globally dispersed multinational organizations
• AS9145 APQP/PAPP, Six Sigma or Lean certification is desirable
• 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

Responsibilities

• Assist in the development and implementation of a plan to systematically align/combine/standardize the QMS documents across Rapiscan Systems sites
• Eliminate ambiguity and misinterpretation within the documentation
• Identify, agree and encompass ‘Best Practices’ within the QMS
• Identify gaps in the QMS and support the creation of new procedures and work instructions to close those gaps
• Ensure processes and procedures are compliant with regulatory bodies and ISO requirements
• Manage documentation control, including version, naming conventions and general documentation storage ‘housekeeping’ (archiving and retrieval)
• Work with all departments to ensure agreement, understanding and implementation of the QMS documented processes and procedures
• Assist in the creation, collection, and presentation of data defined by the QMS
• Lead/support internal and external audits
• Conduct training to new processes/procedures as required
• Able to travel up to 20% of the time
• Uphold the company’s core values of Integrity, Innovation, Accountability, and Teamwork.
• Demonstrate behavior 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.

Benefits

• Base salary is one component of your total rewards package. You may be eligible for long-term incentives, potential discretionary bonuses, and the ability to purchase company stock at a discounted rate through the Employee Stock Purchase Program (ESPP). OSI also offers comprehensive benefits including various options for health plans, access to 401(k) retirement plan, health savings account, disability insurance, life insurance, AD&D insurance, leave of absence programs and an array of voluntary benefits. In addition, paid time off is offered to be used for vacation, holidays, bereavement, and jury duty. Full-Time salaried employees are entitled to flexible time-off.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level