Quality Enigineer II

The Manufacturing 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: quality engineering, support for design controls, supplier quality, risk management processes, tech transfer to operations and quality oversight over the manufacturing processes. 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 (QRS), Canadian Medical Device Regulatory (CMDR), ISO 13485, and In-Vitro Diagnostic
Directive (IVDD). In addition, this individual is a team player participating on design transfer project teams to provide leadership in design
control and risk management practices include working among different business units within the company.

Essential Responsibilities:

• Serve as Quality Core team member on new product development and sustaining engineering project team to provide quality requirement/guidance, oversight for Risk Management in accordance with ISO 14971 and Design/Development/Supplier activities during product lifecycle
• Assist with design or product/tech transfer and process validation activities.
• Develop process validation and verification plans, including Test Method Validation, Gauge R&R and IQ/OQ/PQ. Support execution of process V&V activities and generate reports.
• Develop Preventative maintenance methods for production equipment as applicable.
• Review part drawings to identify critical characteristics.
• Develop and maintain risk management documents such as DFMEA, PFMEA, Hazard Analysis and Risk Management Plans/Reports.
• Review/Approve engineering changes to the design or process of product realization.
• Develop incoming inspection plans and acceptance criteria for incoming inspection and outgoing inspection.
• Responsible to ensure that product design meets quality and compliance standards and design control deliverables.
• Function as consultant for new supplier qualification and audit for CMO and suppliers
• Work cross-functionally with other supplier management personnel, development engineering, material management, procurement and manufacturing teams to resolve suppliers’ quality issues as needed.
• Support disposition of non-conforming material (NCR).
• Drive root cause investigation for supplier product issues and field issues as needed.
• Support corrective and preventive actions (CAPA) implementation
• Work efficiently and effectively in a fast-paced dynamic team environment.
• Ability to work on multiple tasks concurrently with changing priorities.

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
• Experience with Quality Engineering tools such as; FMEA, FTA, 5 Whys, Process Flow etc.
• Strong knowledge of design control, change control, process validation and tech transfer, and in-vitro 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
• Familiarity with the following software a plus:
• Master Control, Quickbase, Minitab, Salesforce, MS Azure Dev Ops (ADO), Smartsheets
• Proficiency in MS Excel
• Ability to review engineering drawings a plus
• Previous experience of production line development or manufacturing experience a plus
• Certified auditor a plus

Target Base Salary Range:

$80K- $111K

Base salary is an integral part of NanoString’s total compensation package.  Base salary considers an individual’s skills, experience, and competitive market value.  The base salary range represent what NanoString pays for a job within a salary grade based on external market data in comparison to similar positions from other companies in our industry. Employees generally enter a salary grade at the lower-to-mid-point in the range.

Other compensation elements include a discretionary annual bonus, incentive compensation for sales roles, Restricted Stock Unit (RSU) grants for all new hires, comprehensive benefit plans and paid time off, including designated holidays.

NanoString is an Equal Employment Opportunity and Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. NanoString does not accept unsolicited agency resumes and will not pay fees to any third-party agency or company that it does not have a signed agreement with.