As one of the world’s leading analytical instrumentation companies, Bruker covers a broad spectrum of advanced solutions in all fields of research and development. All our systems and instruments are designed to improve safety of products, to accelerate time-to-market, and to support industries in successfully enhancing quality of life. We have been driving innovation in analytical instrumentation for over 60 years now. Today, more than 8,500 employees distributed across 90 locations around the world continue to delight our customers with innovative solutions.

Bruker Spatial Biology, a division of Bruker Corporation, provides industry-leading spatial molecular biology solutions consisting of instruments, assays, software, and services to empower life sciences researchers around the world.   Bruker Spatial Biology is comprised of the former Nanostring and Canopy Biosciences product offerings.

The Manufacturing Quality Engineer II supports the quality system processes and activities associated with the manufacturing of Bruker Spatial Biology 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 for current and new product launches.

This individual ensures consistent implementation, improvement, and compliance to the Bruker Spatial Biology Quality System and global regulatory requirements including but not limited to; the FDA Quality System Regulation (QSR), Canadian Medical Device Regulatory (CMDR), ISO 9001, 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 Bruker Spatial Biology Quality System.

Essential Responsibilities:

• Support Manufacturing and Operations in navigating the Quality System including nonconformances, planned deviations, change requests, CAPAs, technology transfer and validations.
• Monitor nonconformances, deviations, complaints, and trends to identify and recommend corrective and / or preventive actions.
• Lead root cause investigations and analyses of issues as assigned.
• Conduct risk assessments for nonconformances, deviations, and document changes.
• Provide Quality leadership on process, test method, and equipment validations.
• Work with Supply Chain and suppliers to resolve MRB and raw material issues.
• 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.

Requirements:

• BS in Life Science or Engineering discipline
• At least 3-5 years of experience in the medical device or biotechnology industry
• Experience with product development within a regulated industry
• Experience with Quality Engineering tools such as; Risk Assessment (pFMEA), Root Cause Analysis (5 Whys, FTA, Ishikawa, Pareto, etc.), Process Flow Maps, etc.
• Strong knowledge of design control, change control, process validation and tech transfer, and in-vitro diagnostic manufacturing
• Working knowledge of Quality for molecular diagnostics assay and instrumentation products
• Working knowledge of Quality System from design control to release of finished product, including FDA 12 CFR 820, ISO 13485, ISO 14971, ISO 9001, the EU MDD, CMDR, & IVDD

At Bruker, base salary is part of our total compensation. The estimated base salary range for this full-time position is between $61,200/yr. and $108,000.00/yr. and provides an opportunity to progress as you grow and develop within a role. The 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.