Sr. Quality Engineer - Integrated Systems

Nextern is hiring for the role Senior Quality Engineer. This role comes with competitive pay and a full benefits package (details below)

The Senior Quality Engineer is responsible for supporting medical electro-mechanical systems and implantable devices manufactured and released to end customers, including Nextern global sites that supply components and product to Nextern US. Work in a global team environment with Nextern production facilities to develop and implement best practices that emphasize defect prevention, process and test variation reduction, and drive continuous improvement activities to meet all device and customer requirements. Responsible for ensuring that components, assemblies, and product meet quality standards. Work as part of project teams to ensure new product introduction and design transfers meet quality project deliverables and requirements.

DUTIES AND RESPONSIBILITIES:

· Quality performance management of assigned product lines.

· Provide proactive support for new product launches and design transfers to ensure that production sites quality meet requirements.

· Mentor quality engineers, technicians, and inspectors on the quality team.

· Support reporting of quality metrics for assigned product lines.

· Facilitate root cause analysis and corrective action management, including management of customer complaints, non-conforming material investigations, and management/support of product/quality system CAPAs.

· Support Quality System, Process, Product Audits and Quality Reviews remotely and onsite at suppliers and Nextern sites, as applicable.

· Work with production sites to improve specifications, develop standards and methods for inspection and test.

· Evaluate quality data to identify process improvements opportunities for supported product lines.

· Create changes orders, deviations, product deliverables. Review change orders, deviations, and product deliverables for compliance to company procedures and for appropriateness within the context of supported product lines.

· Support the use of customer preferred techniques for continuous improvement such as Lean, Six-Sigma, Poka-Yoke, Error Proofing, Measurement System Analysis, Statistical Process Controls (SPC), Equipment Qualification, Process Qualification, Control Plan and Process Failure Mode and Effect Analysis (PFMEA).

· Attend meetings with global teams during US/Costa Rican office hours and during China/Vietnam office hours, as required by assigned projects.

· Contribute to continuous improvement activities.

· Attend various meetings and communicate actions and outcomes effectively.

· Produce reports and presentations.

· Travel up to once per quarter to Vietnam/China/Costa Rica Nextern Facilities

· Undertake professional training and development.

· Independently determine task and approach to daily work and issue resolution.

· Other duties as assigned by management.

SUPERVISORY RESPONSIBILITIES:

· This role may have supervisory responsibilities.

Requirements

QUALIFICATIONS:

· Bachelor's Degree (BA) from four-year college or university and/or training, or equivalent combination of education and experience, preferably in a STEM field.

· Minimum 6+ year relevant production quality/new product introduction experience

· Experience with the full range of ISO 13485 and FDA GMP, as it is associated to Class II and III medical device design, manufacturing, servicing, and distribution.

· Experience writing, changing, and auditing company/site level quality managing system procedures, compliant with ISO 13485 and FDA QSR and GMP desired.

· Experience with risk management as outlined in ISO 14971

· Demonstrated technical expertise and leadership in quality

· Demonstrated use of quality tools and methodologies

· Strong ability to communicate (written and verbally) within and across disciplines and organizational structures on a global scale

· High attention to detail, organization and accuracy

· Computer skills required: MRP Software; Microsoft Office; Project Management Software; Issue Tracking & Collaboration Software; Statistical Analysis Software; Enterprise QMS Software; and Project Management Collaboration Software.

· Excellent Written & Oral Communication Skills.

· Excellent skills in standard computer-based software programs.

· Excellent skills in data analysis to report and present effectiveness of business processes.

Benefits

Nextern offers excellent benefits to fuel you in building a fulfilling life & career:

• Employer subsidized health insurance for employees
• Employer paid dental insurance
• Employer HSA contribution