Quality Assurance EngineerApply Job ID REF9360J Date posted 02/01/2023 Address 40 North Avenue, Burlington, MA Job Type Full-time Job Status Exempt
QSA Global, Inc. specializes in supplying state of the art gamma radiography and portable x-ray systems used in non-destructive testing (NDT) as well as high-quality, high-performance radiation sources used in oil well logging, industrial process control, and medical devices. With over 100 years in organizational experience, we distinguish ourselves as leading experts in design and manufacture of sealed radiation sources and devices, sealed source distribution, video x-ray systems and turnkey services.
QSA Global, Inc. is a division of ITW, a global Fortune 200 diversified industrial manufacturer. The company focuses on profitable growth with strong returns across worldwide platforms and businesses. The businesses serve local customers and markets around the globe, with a significant presence in developed as well as emerging markets.
The Quality Assurance Engineer position, reporting to the Quality Assurance Manager, is responsible for implementing the QA program in accordance with ISO 9001 / ISO 13485, 10 CFR Part 71, and 21 CFR 820 for multiple facilities, primary facility in Burlington MA. Responsible for quality assessments of design and testing of products and processes, corrective action program implementation, and audits (internal and external).
- Develop and maintain process metrics and/or methods, as required, for performance, continuous improvement, and monitoring.
- Lead continuous improvement using the disciplines outlined in the Quality System Manual.
- Implement training and technical tools and drive continuous improvement and efficiencies to support a quality-by-design culture.
- Review and assess changes to standards and regulations applicable to the Quality System and implement to ensure continued compliance.
- Oversee quality projects and provide input to overall quality project portfolio and project priorities.
- Facilitate internal and external audits through leadership; provide training for SMEs/managers/supervisors/directors, then use them to audit departments.
- Act as a CAPA owner for corrective actions necessary to improve the processes within the Quality Management System
- Ensure qualifications and training for auditors is complete and documented.
- Ensure vendor qualification status and documentation is maintained, archived, and updated promptly through collaboration with business SMEs.
- Contribute to the development of continuous improvement of the Quality System Manual and SOPs.
- Contribute to the development of risk-based auditing schedules
- Assist with establishing Quality System metrics and routinely reporting to senior management.
- Support New Product Development projects as needed
- Drive individuals and the team to continuously improve in key operational metrics and the achievement of the organizational goals
- Participate in customer, ISO, FDA and NRC audits
- BS degree, preferably in Engineering or QA systems
- Ability to prioritize multiple tasks
- Experience in MRB, design reviews, supplier audits, corrective action programs
- Thorough understanding of QA standards, implementation, and auditing
- Thorough understanding of statistical techniques and analyses
- Knowledge of inspection techniques
- Experience in internal auditing
- Strong leadership potential and desire to advance career through management development track
- Results driven with excellent verbal, written and collaborative communication skills
- Strong analytical and problem-solving skills
- Proficient in use of Microsoft Office products
Desired Skills and Abilities:
- Minimum 3 years of experience in applied FDA or NRC QA programs
- Auditing programs for QA commitments
- Understanding of NRC radiation safety requirements
- Capable of being certified as a lead auditor under NQA-1
- ASQ certification (CQE, CQA)
We are an Equal Employment/Affirmative Action employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state, or local law.
If you need a reasonable accommodation for any part of the employment process, please contact us by email at HR@QSA-Global.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this e-mail address.
ITW is an equal opportunity employer. We value our colleagues’ unique perspectives, experiences and ideas and create workplaces where everyone can develop their careers and perform to their full potential.
As an equal employment opportunity employer, ITW is committed to equal employment opportunity and fair treatment for employees, beginning with the hiring process and continuing through all aspects of the employment relationship.
All qualified applicants will receive consideration for employment without regard to race, color, sex, gender identity, sexual orientation, religion, national origin, age, disability, protected Veteran status or any other characteristic protected by applicable federal, state, or local laws.
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At ITW, we value our colleagues' unique perspectives, experiences, and ideas and create workplaces where everyone can develop their careers and perform to their full potential.
ITW is committed to equal employment opportunity and fair treatment for employees, beginning with the hiring process and continuing through all aspects of the employment relationship.
All qualified applicants will receive consideration for employment without regard to race, color, sex, gender identity, sexual orientation, religion, national origin, age, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local laws. Read more information here.
If you are a qualified individual with a disability and are unable or limited in your ability to use or access this online application system process due to your disability, please email email@example.com to request assistance. No other requests will be acknowledged.