Senior Quality Engineer - Stillwater, MN, United States - USA 2019-011

Job Title

Senior Quality Engineer

Job Facts

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

Professional Family: 

  • Quality
Reporting To
Product Quality Manager

Kind of contract

Full Time / Part Time
Full Time
Permanent / Temporary
Permanent
Job ID
USA 2019-011

Job Scope

Your Mission

DiaSorin is seeking a highly-qualified Quality Assurance Engineer to fill a critical role in supporting operations and product development for in-vitro diagnostic reagents. This role will serve as the subject matter expert and go-to authority regarding New Product Development and Production Quality Assurance engineering; and will be continually consulted regarding best practices to ensure related activities are performed in a compliant manner that supports business goals.

Main Responsibilities

Your Contributions
  • Maintain/troubleshoot processes and procedures
  • Write technical work plans and prepare, co-author, and deliver technical papers
  • Provide consulting support and advisement to internal and external customers
  • Analyze and translate technical data
  • Recommend methods, techniques, and principles to be applied to ensure compliance, safety, efficacy, and efficiency
  • Conduct equipment/process characterization and documentation activities
  • Make decisions or recommend courses of action with incomplete information
  • Communicate clearly and effectively, both verbally and in writing

Qualifications Experience Personal Strengths Mobility

You
Education
Bachelor’s Degree
Specialization
Quality Assurance
Experience
  • 10 years of direct, job-related experience in Quality Assurance in the Medical Device, Diagnostics, and/or Pharmaceutical industry
  • 5 years of experience as a Manufacturing or Product Development Engineer in the Medical Device, Diagnostics, and/or Pharmaceutical industry
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
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

As per local and Company requirements for DiaSorin Inc. and DiaSorin Molecular
DiaSorin offers a competitive compensation package includes Medical, Dental, Employer Life insurance, STD and LTD insurance, 6% match of 401k plan or Roth
401k plan with vesting schedule

Others Information as per Local Legal Requirements

JOB POSTING REQUIREMENT for USA VACANCIES for DiaSorin Inc. and DiaSorin Molecular LLC
Must be 18 years of age, legally authorized to work in the US; and not require sponsorship for employment visa status (e.g, TN, H1B status) now or in the near future. It is the policy of DiaSorin to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, DiaSorin will provide reasonable accommodations for qualified individuals with disabilities. Our company uses E-verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit https://www.uscis.gov/e-verify EEO is the law. https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Suppleme... (2018)