Quality Engineering Specialist at Kontron Canada focusing on quality processes for embedded computing systems. Engage in audits, internal CAPA, and environmental management in dynamic environments.
About the role
- Senior Quality Engineer providing quality assurance leadership and engineering support at J&J MedTech. Ensuring compliance with regulatory expectations and maintaining product quality throughout the lifecycle.
Responsibilities
- Provides leadership in design and implementation of world-class quality engineering to support entire product life cycle with focus on quality engineering activities such as reliability, risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of the product
- Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes; acts as technical liaison, as needed, between product development, manufacturing, external manufacturers, and suppliers
- Reviews and edits all engineering documentation related to assigned projects, such as technical reports, work instructions and method and process validation; provides review and approval for the release of new products and design changes ensuring quality requirements are met
- Applies intermediate Quality Engineering/Scientific Method techniques and principles to daily tasks and activities.
- Plans and conducts projects and assignments with technical responsibility or strategic input.
Requirements
- A bachelor’s degree in engineering from an accredited engineering or relevant science/technical school is required.
- A degree in Mechanical, Electrical, Biomedical or other equivalent technical degree is preferred.
- Generally requires minimum of 4 years’ work experience.
- Experience in a regulated industry or veterans with leadership experience will be given preference.
- Experience with Risk Management (ISO 14971), Medical Device Quality Management System (ISO 13485), Gage repeatability and reproducibility theory and application, statistics, project management (supporting multiple projects simultaneously), and reliability is strongly preferred.
- Auditing skills such as - ISO, QSR (Quality Systems Regulations), MDSAP, and GMP standards are preferred.
- An ASQ certification (CQE, CQM, CRE or CQA) is an asset.
- Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset.
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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