Quality Engineer - Stillwater, United States - USA 2023-002

Job Title

Quality Engineer

Job Facts

Organizational Area
USA and Canada
Country / State
United States
Place of work
Stillwater
Home/Office based
Office based

Professional Family: 

  • Quality
Reporting To
Manager

Kind of contract

Full Time / Part Time
Full Time
Permanent / Temporary
Permanent
Job ID
USA 2023-002

Job Scope

Your Mission

For over 40 years, DiaSorin has been on a mission on five continents to develop, produce and commercialize diagnostic tests for a wide range of clinical areas. Our tests are designed for hospitals and private testing laboratories, in the markets of immunodiagnostics and molecular diagnostics.

We believe in a respectful and supportive workplace that attracts and celebrates the uniqueness of a diverse workforce that represents our community and customers.

Main Responsibilities

Your Contributions

As a member of the Product Quality Assurance Engineering team, this role will serve as a subject matter expert and go-to authority, regarding best Quality practices and ensuring all Product Quality related activities are performed in a complaint manner to support business objectives. In addition, as a member of the Product Quality Assurance Engineering team, this role will be responsible for serving as an internal consultant on the following activities: Process Controls, Equipment and Process Validation, Nonconforming Product, Risk Management, new Product Development, CAPA, Design/Change Control and Statistical Methods.

Qualifications Experience Personal Strengths Mobility

You
Education
Bachelor’s Degree
Specialization
Biology
Experience

Bachelor's or Master’s degree in Engineering, Life Sciences or related field, or equivalent experience
0-3 years of quality engineering experience in medical device or other regulated industry
Strong expertise in the following disciplines is required:
FDA QSR and ISO 13485, 9001 & 14971 and MDSAP Compliance
CAPA and Root Cause Analysis
Document and Change Control
Nonconformance Process
Validation methodology
Statistical methods (process capability, hypothesis testing, regression/correlation, SPC, DOE)
Computer skills and software knowledge – MS Word, PPT and Excel
Experience with the following preferred:
Immunochemistry/immunoassay
Six Sigma methodology
MDD & IVDD
Quality Auditing (either in performing internal audits and participating in external audits)
Risk Management and usage of PFMEA templates
Familiarity with the following preferred:
Google Suites
Usage of a QMS software system
Familiarity of statistical methods
• Highly developed written and verbal communication skills
• Strong analytical, decision making and problem-solving skills
• Ability to function independently, cooperatively and collaboratively in a team environment

Technical Competencies

Provide QA representation, support and advisement within cross-functional teams relating to (but not limited to):
Non-conforming product
CAPA
Process and Material Validation
Change Management
Design Control and new Product Development
Supplier quality and manufacturing issues
Corporate and local quality plans/projects
Continual improvement of the QMS and product quality
Operational Excellence and Lean projects
Risk Management
Support the NCR (Non-Conformance) system – review and approve issues, make recommendations, monitor efficacy through key NCR process metrics and help to support and drive the success of metrics
Ensure procedures are established and accurate to support new Product Development, Product Design Transfer and manufacturing process
Review design and development processes, ensuring appropriate documentation is established in accordance with the Design Control procedures
Review manufacturing and product development validation activities to ensure that they are well established, risk based and compliant with applicable regulations.
Review, approve and provide recommendations on Change Requests.

Skills

Gather, analyze and report data reflecting status of product and process and provide recommendations to improve such activities
Use statistical tools to analyze data to make acceptance decisions and improve processes and product
Review and approve equipment and process validation protocols/reports
Recommend methods, techniques and principles to ensure compliance, safety, efficacy and efficiency
Work with manufacturing and supply chain to resolve supply issues of critical components, sub systems and finished product to ensure that all changes are appropriately validated
Initiate, investigate, own, drive and/or participate in NC and CAPA issues as needed
Analyze and translate technical data
Participate on internal audit team and support external audits
Perform other duties as assigned.

Languages
English
Travel Availability
NA
Relocation Availability
NA
Training Required

YES

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.