Operations Quality Engineer II

6 days ago

Bothell, United States Bruker Full time

Overview

The Operations Quality Engineer II supports the quality system processes and activities associated with the manufacturing of NanoString products. The scope of this position includes quality engineering, support for design controls, supplier and incoming quality, risk management, and quality oversight over manufacturing processes.

The Operations Quality Engineer II provides technical, quantitative, and coordination support to assure products and processes are designed, deployed, and operated according to requirements. Work scope of this position includes management of key processes relating to quality engineering tasks, ensure robust design controls, supplier quality, risk management, tech transfer to manufacturing operations and driving KPI affecting quality in manufacturing.

This individual ensures consistent implementation, improvement, and compliance to the NanoString Quality System and global regulatory requirements including, but not limited to; the FDA Quality System Regulation (QSR), Canadian Medical Device Regulatory (CMDR), ISO 13485, and In-Vitro Diagnostic Directive (IVDD) and In-Vitro Diagnostic Regulation (IVDR). In addition, this individual provides guidance to Manufacturing and Operations in navigating the NanoString Quality System.

Responsibilities

Essential Responsibilities:

Support Manufacturing and Operations in navigating the Quality System including SCARS, nonconformances, deviations, change requests, CAPAs, and validations. Monitor SCARS, nonconformances, deviations, complaints, and trends to identify and recommend corrective and / or preventive actions. Conduct root cause investigations and analyses of issues as assigned. Conduct risk assessments for SCARs, nonconformances, deviations, and document changes. Provide Quality leadership on process, test method, and equipment validations. Work with Supply Chain and suppliers to resolve raw material issues. Manage the review and approval of Molecular diagnostic &/or Instrument DHRs (Batch Records). Implement appropriate process monitoring and control methods consistent with the level of process/product risk using customer feedback. Support customer complaints investigations and supplier audits Collaborate with Manufacturing, Manufacturing Engineering, New Product Introduction, Procurement, Quality, and Supply Chain partners as well as vendors on the above activities Basic application of statistical tools and methods.

Qualifications

Requirements:

BS in Life Science or Engineering discipline At least 3 years of experience in the medical device or biotechnology industry Experience with product development within a regulated industry Hands on experience with Quality Engineering tools such as; Risk Assessment (pFMEA), Root Cause Analysis (5 Whys, FTA, Ishikawa, Pareto, , Process Flow Maps, etc. Strong knowledge of design control, change control, process validation and tech transfer, and in-vitro molecular diagnostic manufacturing. Working knowledge of Quality System from design control to release of finished product, including FDA 12 CFR 820, ISO 13485, ISO 14971,the EU MDD, CMDR, & IVDD

Preferred Qualifications

ASQ certified or CQE a plus Certified auditor a plus Experience providing Quality support of molecular diagnostics products

At Bruker, base salary is part of our total compensation. The estimated base salary range for this full-time position is between $78,000 and $127,000 provides an opportunity to progress as you grow and develop within a base salary for the role will depend on a several job-related factors, including, but not limited to education, training, experience, the geographic location of the successful candidate, skills, competencies, job-related knowledge and travel requirements for this position. Full-time employees may also be eligible for a performance-related incentive in addition to a full range of benefits including 401(k) with company match, an employee stock purchase plan, medical and dental plans, life insurance, short-term and long-term disability insurance, employee assistance program and paid time off including vacation, sick time and holidays, and more.

Bruker is an equal-opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

Certain positions at Bruker require compliance with export control laws and as a result, all interviewed candidates for all positions will be screened pre-interview to determine their eligibility in light of export control restrictions.

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