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Medical Device Operations Jobs in Arizona (NOW HIRING)

... Medical Device Manufacturing performance. The position is on the Site Leadership Team and advises the Manufacturing Site Director and extended Operations leadership team on strategy and business ...

... Medical Device Manufacturing performance. The position is on the Site Leadership Team and advises the Manufacturing Site Director and extended Operations leadership team on strategy and business ...

... Medical Device Manufacturing performance. The position is on the Site Leadership Team and advises the Manufacturing Site Director and extended Operations leadership team on strategy and business ...

This role is integral to Banner Health's medical device security program, ensuring compliance and ... Operations (experience with information technology related to workstations, networking, and ...

This role is integral to Banner Health's medical device security program, ensuring compliance and ... Operations (experience with information technology related to workstations, networking, and ...

QA/QC Engineer II

Phoenix, AZ · On-site

$71K - $92K/yr

... operational equipment is timely calibrated and validated. Minimum: * Bachelor's degree in ... Experience in manufacturing of medical device with electronic components is preferred. * Broad ...

QA/QC Engineer II

Phoenix, AZ · On-site

$71K - $92K/yr

... operational equipment is timely calibrated and validated. Minimum Qualifications Minimum ... Experience in manufacturing of medical device with electronic components is preferred. * Broad ...

Dip Mold Operator

Tempe, AZ · On-site

$16.50 - $19.75/hr

... operational needs.Perform other duties as assigned.QualificationsHigh school diploma or GED required.Previous manufacturing, assembly, or medical device production experience preferred.Ability to ...

Dip Mold Operator

Tempe, AZ · On-site

$16 - $19.50/hr

... to support operational needs. Perform other duties as assigned. Qualifications High school diploma or GED required . Previous manufacturing, assembly, or medical device production experience ...

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Medical Device Operations information

What is the difference between Medical Device Operations vs Medical Device Quality Assurance?

AspectMedical Device OperationsMedical Device Quality Assurance
Primary FocusManaging manufacturing, supply chain, and product deploymentEnsuring product quality, compliance, and safety standards
Required CertificationsRegulatory knowledge, manufacturing certificationsQuality management certifications, ISO standards
Work EnvironmentManufacturing plants, supply chain settingsQuality labs, compliance departments
Industry UsageUsed across production and logistics teamsUsed within quality control and regulatory teams

Medical Device Operations and Medical Device Quality Assurance roles often overlap but focus on different aspects of the product lifecycle. Operations centers on manufacturing and logistics, while Quality Assurance emphasizes compliance and safety. Both roles require regulatory knowledge and are essential in the medical device industry.

What are some common challenges faced by professionals in medical device operations, and how can they be addressed?

Professionals in Medical Device Operations often face challenges related to maintaining strict regulatory compliance, ensuring product quality, and managing cross-functional communication between manufacturing, quality assurance, and regulatory teams. Staying up to date with changing FDA or international regulations is essential, and frequent documentation or process audits can be demanding. Building strong organizational habits, leveraging digital tracking tools, and fostering open communication channels with other departments can help address these challenges and ensure smooth operations.

What is medical device operations?

Medical device operations refer to the processes and activities involved in the manufacturing, assembly, quality control, supply chain management, and distribution of medical devices. This field ensures that devices are produced efficiently, meet regulatory standards, and are delivered safely to healthcare providers and patients. Operations teams collaborate with engineering, quality assurance, and regulatory departments to maintain compliance and optimize production workflows. Their work is crucial for ensuring that medical devices are safe, effective, and readily available for patient care.

What are the key skills and qualifications needed to thrive in medical device operations?

To thrive in Medical Device Operations, you need a solid understanding of regulatory compliance, quality assurance, and supply chain management, often supported by a degree in engineering, life sciences, or business. Familiarity with quality management systems (QMS), FDA regulations, and software like ERP systems is typically required. Strong organizational skills, attention to detail, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring compliance. These competencies are vital for delivering safe, high-quality medical devices efficiently and in accordance with rigorous industry standards.

What job categories do people searching Medical Device Operations jobs in Arizona look for?

The top searched job categories for Medical Device Operations jobs in Arizona are:

What cities in Arizona are hiring for Medical Device Operations jobs?

Cities in Arizona with the most Medical Device Operations job openings:

Infographic showing various Medical Device Operations job openings in Arizona as of August 2026, with employment types broken down into 1% As Needed, 80% Full Time, 14% Part Time, and 5% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution.

Staff Quality Engineer - Product Development, Tempe, AZ - (IK)

Central Business Solutions

Tempe, AZ • On-site

$110K - $115K/yr

Full-time

Re-posted 22 days ago


Job description

Job Responsibilities:
  • Technical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance) and chemical and pharmaceutical operations (e.g., drug product manufacturing, analytical testing, process development and quality assurance)
  • Ability to create, support, review, and investigate analytical test methods used to support pharmaceutical combination devices.
  • The ability to create, support, review chemistry, manufacturing, and controls device submissions
  • Participates as team leader or as an active member of the team to meet company objectives and ensure department responsibilities are completed
  • Leads development of risk assessments and test method activities (e.g., development and validation for physical and analytical test methods)
  • Leads component qualifications, design validation, design verification, drug stability and process validation
  • Leads product investigations
  • Ability to make and present risked based decisions
  • Assess product changes against product design
  • Supports translation of design inputs into manufacturing control plans
  • Develop and implement procedures to comply with corporate and industry standards.
  • Coordinates and/or directs all aspects of product development activity related to a product line
  • Leads development of risk assessments and test methods
  • Quality engineering representation on Product Development and Design Review teams
  • Prepare and present project updates and technical discussions
  • Participate in project planning, budgeting, scheduling, and tracking
  • Support internal and external supplier audits
  • Provide support to the regulatory department in writing technical submissions
  • Complies with company procedures and policies, government regulations
  • Actively participates in training and providing input to training of employees on division procedures and policies
  • Ability to travel for business, project, and issues approximately up to 25% of time.
  • Other duties and projects, as assigned

Required Education and Experience:
  • BS in Engineering, Biological Science, or a related engineering field (Masters or Ph.D preferred). Fields of study include Chemical Engineering, Bioengineering, Pharmacy, or Biochemistry
  • Minimum of eight years of experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry
  • Extensive proven understanding of design controls in development stage
  • Pharmaceutical or combination product experience

Required Qualifications:
  • Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)
  • Ability to lead creation of risk management files
  • Ability to develop solutions with business impact
  • Advanced statistical and risk assessment techniques
  • Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies
  • Ability to make and present risk-based decisions
  • Strong interpersonal skills
  • Ability to analyze and optimize manufacturing and quality systems
  • Product, design & prototyping
  • Ability to create and provide training
  • Problem solving ability
  • Ability to create, review and coordinate test protocols and reports
  • Ability to generate engineering proposals
  • Oral and written presentation skills
  • Ability to lead cross functional teams
  • Understanding of regulatory requirements including ISO 13485, ISO 14971, 21 CFR 210/211/820 , ICH Guidelines

Skills and Certifications
Drug Device delivery combination products
Compensation
Base Salary - USD $110,000 to $115,000
Full-time
Benefits - Full
Relocation Assistance Available - Possible for ideal candidate
Candidate Details
8+ to 10 years experience
Seniority Level - Mid-Senior
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally
Ideal Candidate
8+ years experience in New Product Development of combination devices
Central Business Solutions, Inc(A Certified Minority Owned Organization)
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Central Business Solutions, Inc
37600 Central Court Suite 214 Newark CA, 94560
Phone: (833)247-8800 Fax: (510)-740-3677
Web: http://www.cbsinfosys.com