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DiaSorin Hiring for Sr Mgr, Product Quality Assurance & Asset Mgmt at Stillwater, MN  Full Time

Job Description

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.

Job Title

Senior Manager, Product Quality Assurance and Asset Management

Reports To

Director, Quality Assurance

Department

Quality Assurance 647

Supervises

Quality Engineer, Sr. Quality Engineer, Microbiologist, Calibration Manager

Location

DiaSorin Inc. Stillwater

Travel

Up to 10%

Purpose and Objectives

This role will serve as the subject matter expert and go-to authority regarding product development, product quality assurance, microbiology (bioburden and environmental monitoring) and asset management.

This role will be continually consulted regarding best practices to ensure that Product Development, Production activities, microbiology and asset management are performed in a compliant manner that supports business roles.

Job Tier(s)

Job Title

Job Tier

Manager, Product Quality Assurance and Asset Management

Senior Manager, Product Quality Assurance and Asset Management

Tier IIA: Manages/Supervises People

Tier I: Executive Leadership

Tier IIA: Manages/Supervises People

Tier IIB: Principal Contributor

Tier III: Salaried Individual Contributors

Tier IV: Non-Exempt/Hourly

Tier V: Contract, Temporary Employee, Intern

Education

Job Title

Requirement

Manager, Product Quality Assurance and Asset Management

Senior Manager, Product Quality Assurance and Asset Management
  • BS/BA required, MS preferred in Life Sciences, Engineering and/or Quality Management or Quality Assurance

Experience

Job Title

Requirement

Manager, Product Quality Assurance and Asset Management

Senior Manager, Product Quality Assurance and Asset Management
  • 7 years in quality, regulatory, compliance manufacturing, operations and/or engineering within the IVD medical device industry
  • Minimum of 3 years people management experience
  • 10 years in quality, regulatory, compliance manufacturing, operations and/or engineering within the IVD medical device industry
  • Minimum of 5 years people management experience

Desired Qualifications

Job Title

Qualification

Manager, Product Quality Assurance and Asset Management

Senior Manager, Product Quality Assurance and Asset Management
  • Demonstrated knowledge of FDA regulations, ISO 13485, ISO 14971, IVDR, other national and international regulations and standards
  • Experience with direct contact with FDA and ISO Registrars, IVDR Notified Bodies
  • Knowledge of environmental monitoring processes
  • Knowledge of Asset Management – Preventive Maintenance, Repairs, Calibration, etc.
  • Strong leadership, project management skills and ability to influence others

Competencies

Job Title

Competency

Manager, Product Quality Assurance and Asset Management

Senior Manager, Product Quality Assurance and Asset Management
  • Strong analytical skills, exceptional writing and interpersonal relationship skills
  • Competency in the management of Design Controls, Process Controls, Risk Management and Validation (including Equipment, Software and Process)
  • Competency in environmental monitoring and asset management/tracking related to equipment – procurement, qualification, repair, preventive maintenance, calibration, etc.
  • Competency in Document and Change Control, Quality Audits, CAPA including Root Cause Analysis, Nonconformance Records management
  • Understanding of immunoassay principles
  • Demonstrated organizational, management and communication skills

Interfaces

This position interfaces with

  • Internal

  • External
  • Internal and External DiaSorin personnel
    • Manufacturing / QC
    • Critical Raw materials
    • Regulatory Affairs
    • Operational Excellence
    • Logistics/procurement
    • Finance
    • Human Resources
    • Product Development
  • External Providers
  • Health and Regulatory Authorities
  • Notified Bodies and Registrars

Key Duties/Responsibilities

Job Title

Key Duties/Responsibilities

Manager, Product Quality Assurance and Asset Management

Senior Manager, Product Quality Assurance and Asset Management
  • Participate in the Quality Assurance management team to set priorities and policy for the team to ensure support of the organization
  • Provide leadership to the Product Quality Assurance and Asset Management team, ensuring clear and aligned objectives, supporting employee development, and encouraging collaboration across the organization
  • This role will be continually consulted regarding best practices to ensure that Product Development, Production activities, Validation, Environmental Monitoring, Bioburden, Risk Management and Asset Management are performed in a compliant manner that supports business objectives
  • Responsibility for the Risk Management process
  • Responsibility for site’s Quality Improvement Plan
  • Oversite/responsibility for the asset management software and tracking system and analysis of related metrics
  • Oversite of the environmental monitoring and bioburden processes and associated metric reporting
  • Establish and maintain procedures and process for the handling of Nonconforming Material
  • Establish and maintain procedures and process for Asset Management, including validation, PM, tracking, qualification
  • Establish and maintain procedures and process for Environmental Monitoring
  • Participate in QMS and regulatory audits, management review, reporting of quality metrics, review of quality records and other major projects to support the organization.

Requirements

Category

Average

Advanced

Superior

Mathematical skills

X

Written communications

X

Analytical capability

X

Ability to grasp complex concepts

X

Job Hazards

Category

Frequency (hours per 8-hour shift)

0-1

1-3

3-8

Toxic, Corrosive Chemicals

X

Dust, Airborne Particulates

X

Human Source Materials (Biohazards)

X

Radiation (Ionizing)

X

Noise (interferes with ability to hear normal speech)

X

Extreme Cold

X

Extreme Heat

X

Vibration

X

Laboratory Animals

X

Other

X

Physical Effort

Category

Frequency (hours per 8-hour shift)

0-1

1-3

3-8

Heavy Lifting (>50 lbs)

X

Standing

X

Pushing

X

Pulling

X

Sitting

X

Bending at Waist

X

Walking

X

Climbing Stairs

X

Reaching

X

Repetitive Hand, Arm, Shoulder Movements

X

Fine Manipulation

X

Other

X

Special Dress

Category

Frequency (hours per 8-hour shift)

0-1

1-3

3-8

Face Protection (Face Shield/Mask)

X

Respirator

X

Chemical Resistant Clothing/Gloves

X

Safety Shoes

X

Safety Glasses

X

Hair Net

X

Hearing Protection

X

Lab Coat

X

Surgical Gloves/Disposable Gloves

X

Disposable Clothing/Shoe Covers

X

Other

X

Sensory Ability

Category

Required

Not Required

Ability to Smell (Respirator Users)

X

Correctable Vision (Inspection Work)

X

Ability to Distinguish Color (Label Inspection)

X

Other:

X

What we offer

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.

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:. 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:or call toll-free 1.800.328.1482.

 

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Job Overview

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  • Location:
  • Job Title: DiaSorin Hiring for Sr Mgr, Product Quality Assurance & Asset Mgmt at Stillwater, MN 
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