Quality Assurance Specialist

3 weeks ago

Reston, Virginia, United States Laborie Full time
Quality Engineer Job Description

Laborie Medical Technologies is seeking a highly skilled Quality Engineer to join our Quality team in the Salt Lake City office.

The Quality Engineer will be responsible for ensuring product and process conformity to requirements, ensuring documentation in conformance to the Quality Management Systems and applicable standards and regulations.

Key Responsibilities:
  • Provide quality engineering support for quality manufacturing's design & development
  • Perform investigations related to complaints and or service
  • Support design and engineering change processes
  • Perform inspections (e.g. First Article Inspections DHR inspections) before and after product / process release
  • Support internal audit activities and follow-up on nonconformities and other findings (e.g. through GA-actions or CAPA) with internal process owners and suppliers
  • Co-host external audits in concert with quality systems team for the company
  • Periodic review of DHR and production records of both internal manufacturing facilities and critical contract manufacturers
  • Perform process (re-)validations and QMS Software (re)validations as required
  • Review and approve documented product-nonconformities (NCRs) before closure
  • Verify segregation and blocking of NC product and verify that released for use or reworked materials/components meet all specifications
  • Bring CAPA worthy improvement forward to the cross-functional teams
  • Collect quality data and trending data for Management Review and Post Market Surveillance: from complaints (complaint rates failure mode statistics) in-production product-nonconformity records (NCR rates failure mode statistics) and supplier deliveries (supplier NCR rates)
  • Supports operations and supplier controls including supplier risk classifications qualifications approval/releases monitoring scorecards and periodic (re)evaluation
  • CAPA process: support QARA team to drive CAPA planning's containment actions implementation and effectiveness checks with process owners
  • Perform inspections for containments verify and approve implementation of actions plan and perform effectiveness checks
  • Participate in process and product risk assessments (e.g. pFMEAs dFMEA) for existing and new product development projects and ensure implementation of documented risk mitigation controls in product realization processes
  • Maintain awareness and culture for quality and compliance in the organizations at all levels of your interaction
  • Raise any (potential) concerns to your manager
  • Bring suggestions for preventive actions to your manager
  • Work within policies, strategies, priorities, and guidance of your manager
  • Participate in global and local project work streams to represent QA G (e.g. SAP projects e-QMSs Laborie Procedure Harmonization's EU-MDR)
Requirements:
  • University degree at Bachelor or Master level. A Technical/Engineering/Physics/Biomed degree is preferred
  • Minimum of 5 years Experience in QA Engineering in an GSO preferred) or GSO 9001 certified organization
  • Experience in QA and any other functions covers: Productions Design Transfers Purchasing Controls Complaint Handlings Warehousing's Design/Engineering changes Design controls
  • Experience with Risk Management (e.g. GSO 14971 or other industry standard) is preferred
  • Experience with (Medical Devices or other industry) Electrical Equipment and a basic understanding of related GEC product safety standards (e.g. Medical Devices GEC series) is preferred – ability to work with R&D and QA-GEC experts within Laborie
  • Experience with Medical Devices quality management systems standards is preferred (e.g. GSO 13485s USA QSR)
  • Experience as quality auditor. Lead auditor qualifications and GSO 19011 Quality System Auditor training/certification is preferred
  • Likes to work both independently with people and in teams with local and global peers and cross-functional colleagues
  • Soft skills and personality: influential skills and pervasive tenacious firm. Knows to build and balance respectful mutual relations. Knows when and how to escalate issues. Team player. Knows to give people relative freedom for 'how to do things' while keeping control on the 'what must be met and achieved'. Project management skills. Positive change agent. Tunes to company priorities and has a serving attitude to help others to make their time lines
  • Fluent in English verbal and in writing
  • Travel to Switzerland and other Laborie locations in USA (e.g. Vermont Minnetonka) and Canada (e.g. Toronto/Mississauga) may be required on a regular basis (e.g. once per quarters or more frequent in case of projects)
  • Training (courses and self-study) may be required. Positive attitude to invest some own time in further training and development as required
What We Offer:
  • Unlimited PTO
  • 10 paid holidays/year—7 official and 3 of your choosing
  • Very flexible Hybrid work schedule--it's about the work, not the timeclock
  • Company paid: Short & Long Term Disability, Basic Life and AD&D Insurance
  • Access to Cigna Medical, Dental, Vision insurance plus loads more
  • 6 Weeks consecutive Parental Leave at 100% pay, within 1 year of the birth or adoption; birthing moms could also receive short term disability coverage at 60% of pay
  • $5,000 Adoption Reimbursement
  • Company Matching on retirement plans
  • Paid time off to volunteer in your community
  • Access to free financial wellness planning through Prudential
  • Access to free whole health and life resources through our employee assistance program LifeWorks

Laborie is a specialty manufacturer and supplier of medical technologies and devices, committed to excellence in diagnostics and therapeutics for Urological, Gastrointestinal, Obstetric, Gynecological, and Neonatal healthcare and committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education and employment for individuals with disabilities.

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