What are the responsibilities and job description for the Medical Device Quality Assurance Engineer position at System One?
Job Title: Medical Device Quality Assurance Engineer
Location: West Valley City, UT
Hours/Schedule: Mon- Fri 8am 5pm
Type: Contract
Responsibilities
Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:
Requirements
Education/Special Training Required
Qualifications/Work Experience Required Who We Want
A Quality Engineer with the ability to drive quality and deliver results. Someone who is an advocate for quality and lean methodologies; a self-directed professional who can identify issues and communicate effectively to all levels within the organization; a medical device industry professional who is passionate about providing superior quality products to patients and customers.
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
Ref: #558-Scientific
Location: West Valley City, UT
Hours/Schedule: Mon- Fri 8am 5pm
Type: Contract
Responsibilities
Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:
- Work closely with operations and the business functions to ensure quality performance of product and processes.
- Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.
- Lead and participate in the development and improvement of the manufacturing processes for existing and new products.
- Resolve quality issues with suppliers and partner with internal customers.
- Review and approval of change management activities.
- Maintain KPI for monitoring of process and supplier quality, perform analysis and interpret trends, take action as necessary.
- Ownership and reporting on all quality issues associated with assigned suppliers. Ensure all assigned supplier related material quality issues are effectively communicated to key stakeholders.
- Maintenance of the Approved Supplier List (ASL) in conjunction with the Global Sourcing, Supplier Controls and Audit functions.
- Support execution and analysis of QATs.
- Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
- Proficient in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.
- Proficiency in and makes continuous strides towards optimization of inspection methods and sampling. Support First Article Inspections.
- Proficiency in statistical methods and application.
- Proficiency in technical understanding of manufacturing prints and tolerancing.
- Support global supplier audit team with key supplier site metrics. Negotiate sustaining quality agreements with suppliers.
- Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.
- Assist in the development, responsible for review & approval of process and equipment validation/qualification.
- Support manufacturing transfers to other plants/facilities, leading quality activities.
- Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.
- Coach others in quality topics and activities.
Requirements
Education/Special Training Required
- Bachelor of Science, Engineering or related subject with 2 or more years of experience in a quality or engineering discipline in a manufacturing environment, or
- Master of Science, Engineering or related subject with 0 or more years of experience in a quality discipline
Qualifications/Work Experience Required Who We Want
A Quality Engineer with the ability to drive quality and deliver results. Someone who is an advocate for quality and lean methodologies; a self-directed professional who can identify issues and communicate effectively to all levels within the organization; a medical device industry professional who is passionate about providing superior quality products to patients and customers.
- Previous experience in a regulated environment desirable (e.g. Medical Device, Aviation, Aerospace, Automative, Defense).
- CQE or equivalent course work / experience desirable
- Proficient in understanding of Med Device manufacturing processes desirable.
- Familiarity with ISO 13485, GDP, GMP desirable.
- Lean Six Sigma training a distinct advantage.
- Excellent collaboration and communication skills and attention to detail. Able to effectively communicate up/down and across different levels of the organization.
- Have a good understanding of engineering and quality practices & methods.
- High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
- Self-starter with demonstrated efficient work methods, analytical & problem-solving skills and ability to handle multiple tasks in a fast paced environment.
- Must be willing to work as part of a multi-site team, with some travel required.
- Working knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.
- Highly developed problem solving and strong analytical skills.
- Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach.
- Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.
- Manages change well and adopts a continuous improvement orientation to the role
- Excellent English (both oral and written)
- Ability to be the voice of Quality when dealing cross functionally
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
Ref: #558-Scientific
