Quality Engineer
3 weeks ago
The Quality Engineer actsas the primary contact for operations on all quality issues. This individual supports the launch and sustaining production of Class I and II Medical Devices. They assure Value Stream activities remain in compliance with FDA/ ISO regulations/ standards/ guidelines, facility SOPs and Policies, and customer requirements, supporting organizational Quality/ Business Goals and Objectives while providing team leadership support for process improvement projects, namely quality and productivity increases, and cost and scrap reductions.
MAIN JOB RESPONSIBILITIES:
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Follow and comply with FDA Quality Systems Regulations, ISO Standards and SOPs as defined by Viant Medical’s policies and procedures.
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Continuously reviews methods, procedures, processes, etc. to determine improvements related to quality and cost to reduce scrap and increase efficiencies, implements and motivates co-workers to recommend improvements
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Independently leads problem-solving efforts, including customer complaint investigations and analysis to identify and resolve sporadic and chronic quality issues in a timely manner to ensure production of safe and effective medical devices
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Assists in writing nonconformance reports; reviews nonconformance reports initiated by staff; provides feedback to management on results, provides solutions and recommendations when applicable; recommends studies and analysis to solve nonconformance and Quality problems
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Initiates writing necessary documents needed for product launch such as MVP Master Validation Plan and Component Risk Protocol
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Initiates writing necessary documents needed for TMVs Test Method Validation and provides support in execution
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Initiates writing necessary documents needed for component and in-process device inspections
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Participates in IQ/OQ/PQ/PV activities including the drafting or review of protocols and reports, PFMEAs and other risk analysis documents, assists in qualification, validation of production processes
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Independently performs machine and process capability and performance studies; recommends and, upon approval, leads and implements changes and upgrades to systems, procedures and processes to improve product Quality
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Assesses compliance with applicable regulations within the manufacturing processes and recommends improvements to ensure that safe and effective products are produced
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Trains Quality Assurance Inspectors and manufacturing personnel in understanding specifications, new product audits, procedures, environmental controls, and requests training or training support
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Leads or participates in internal/external Quality System audits
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Assists in the assessment of Viant’s Supplier Development Program; addresses problems and recommends solutions to supplier quality; interfaces as necessary to ensure product specifications are met
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Reviews potential changes to products in production for reliability impact to aid in the correction process, design or material problems
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Maintains effective working relationships, communications and feedback with all other departments
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Performs other duties as required
POSITIONREQUIREMENTS:
Knowledge/Education:
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BS in Engineering, Science or related field, or equivalent experience and training
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Knowledge of FDA QSR, ISO13485, ISO14971 Risk Assessment desirable
Job Experience:
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3-5 Years relevant Quality Engineering experience
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Experience inMedical Device, Healthcare or Pharmaceutical preferred, but not required
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Experience in Customer-Focused Quality and/or Business Process Improvement
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Lean Manufacturing experience
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Working knowledge of statistical techniques
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Working knowledge of quality and reliability software
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Ability to work in a team environment
Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn.
Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.
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