Quality Engineer - Stillwater - Minnesota - USA - Stillwater, United States - USA 2021-039

Job Title

Quality Engineer - Stillwater - Minnesota - USA

Job Facts

Organizational Area
USA and Canada
Country / State
Stati Uniti
Place of work
Stillwater
Home/Office based
Office based

Professional Family: 

  • Quality
Reporting To
Director, Quality

Kind of contract

Full Time / Part Time
Full Time
Permanent / Temporary
Permanent
Job ID
USA 2021-039

Job Scope

Your Mission

We are looking for a Quality Engineer who thrives in a fast-paced environment and is excited to be involved in New Product Development, CAPA process, audits and more. Your ability to provide leadership in the application of Quality Tools such as Risk Management, Root Cause investigations and Capability Studies will be instrumental to the team and the organization.

Main Responsibilities

Your Contributions

• A great Quality Engineer focuses on New Product Development- review of design and development processes and ensuring that appropriate documentations are established during this process and in accordance with the Design Control procedures.
• Use your strong decision making and communication skills, as well as Software and Equipment Validation experience.
• NCMR system - review issues, recommends CAPA, review investigation reports, monitor efficacy, and close NCRs in a timely fashion.
• Establish methods to analyze and investigate the root cause of external and internal non-conforming products.
• Analyze data from customer complaints, internal audits, and internal and external suppliers non-conformance and implement appropriate solutions.
• Participate in Audits (Internal and External), and Regulatory authority inspections and ensure that risk to company is minimized as much as possible.

Qualifications Experience Personal Strengths Mobility

You
Education
Bachelor’s Degree
Specialization
Engineering
Experience

• Bachelor’s Degree preferred in an Engineering or life sciences discipline such as Mechanical, Electrical Industrial, Manufacturing Engineering, Biochemistry, Chemistry, Microbiology, Biotechnology or Bio-Engineering.
• Related experience in IVD, medical devices, or pharmaceutical industry.
• Must have a thorough understanding of statistical analysis, statistical process control, Investigation and Root Cause Analysis, Corrective and Preventive Action Process, and their application to development and manufacturing processes as a problem identification and resolution tool.
• CQE certification and/or Green Belt or above preferred.

Technical Competencies
  • Strong expertise in the following disciplines is desired: equipment control/ qualification, process validation, analytical and test method validation, design controls, risk management, process control, non-conformances, CAPA, quality audits, change management
    customer support in a fast-paced environment are all paramount
  • This position will best be filled by an experienced and results oriented professional with the ability to lead or participate in continuous improvement initiatives and projects that impact the QMS and product quality
Skills
  • Attention to detail, strong analytical, decision making and problem solving skills, mature communication skills, excellent writing ability, and the capability to maintain high levels of multi-tasking
Languages
English
Travel Availability
N/A
Relocation Availability
Domestic USA candidates only eligible to work in the U.S.
Training Required

N/A

Benefits

We Offer You

Receive a competitive salary and benefits package as you grow your career at DiaSorin. Join our team and discover how your work can impact the lives of people all over the world.

Others Information as per Local Legal Requirements

We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.
This contractor and subcontractor shall abide by the requirements of 41 CFR 60-1.4(a), 41 CFR 60-300.5(a) and 41 CFR 60-741.5(a). These regulations prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities, and prohibit discrimination against all individuals based on their race, color, religion, sex, sexual orientation, gender identity or national origin. Moreover, these regulations require that covered prime contractors and subcontractors take affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
DiaSorin Inc and DiaSorin Molecular LLC are Affirmative Action and Equal Opportunity Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Equal Employment Opportunity
Posters: https://www.dol.gov/agencies/ofccp/posters.
If you’d like to view a copy of the company’s affirmative action plan or policy statement, please email: hrtalent@diasorin.com. If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail: hrtalent@diasorin.com or call toll-free 1.800.328.1482.