Quality Engineer II-Medical Devices

 

 

FULLY ONSITE POSITION

 

Who We Are:

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

 

Job Summary:

In this role, you will plan, schedule, execute and communicate all items regarding quality issues, complaints, validations and other projects to QA Senior Supervisor and Program Manager and/or other interested parties.  Be a strong advocate for product, process, and system quality at all stages of product realization. Participate in steering committees which originate from both customer and manufacturing facilities.  Support customer complaint data acquisition, root cause analysis, corrective action and complaint handling.  Also perform all duties associated with the auditing and documentation of compliance related items against GMP and ISO standards.

 

Essential Duties and Responsibilities:

•  Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• Review and approve product / process deviations or rework documentation.
• Provide quality reports and review trending on assigned areas of responsibility.
• Work independently and with project teams to develop deliverables including quality plans, manufacturing & inspection documentation, test methods, and any other necessary quality records.
• Participate in the development and maintenance of product risk and hazard analysis in accordance with ISO 14971.
• Meet company and departmental goals in the continuous improvement of all products, services and processes.
• Support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer’s experience.
• Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence.
• Maintain information and statistics on program’s quality performance on a monthly basis.
• Perform DOEs (Design of Experiments) to help improve and optimize new and/or existing plant processes or job protocols.
• Complete auditor certification and perform internal ISO and quality systems audits in accordance with ISO standards including recommending ways to resolve any issues identified by the audits.
• Performs other duties as assigned based on business needs.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.

Basic Qualifications: 

• Education or Equivalent Experience:- Bachelor's in Science, Operations, or Business

• Experience: 3-5 years of experience
• Experience using Six Sigma & SPC tools and techniques
• Experience with drug handling and medical device regulations (21 CFR 210, 211, and 820)
• Experience with ISO 9000 and ISO 13485 standards and GMPs
• Excellent written and oral communication skills
• Excellent critical reading and writing skills
• Problem solving including root cause failure analysis methods
• Planning/organizational skills
• Negotiating
• Computer skills required especially MS office applications and statistical analysis systems
• General understanding of manufacturing and plant operations

 

Preferred Knowledge, Skills and Abilities:

• ASQ certification (CQE or CQA)
• Green or Black Belt certification
• Chemistry or Engineering Degree
• Graduate degree
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Support and contribute in Lean