Senior QMS Process Engineer - Katalyst Healthcares and Lifesciences - Remote | Dice.com

Katalyst Healthcares and Lifesciences

Apply Now

Senior QMS Process Engineer

Remote • Posted 30+ days ago • Updated 59 minutes ago

Full Time

On-site

Apply Now

Fitment

Dice Job Match Score™

To see how well you match this job, please log in or create an account.

Once logged in, be sure to complete your profile to get the most accurate match score.

Fitment

Dice Job Match Score™

⭐ Evaluating experience...

Job Details

Skills

Regulatory Compliance
Change Management
Medical Devices
QMS
ISO 13485
Application Lifecycle Management
Jama
Product Development
Quality Assurance
Research and Development
Organizational Skills
Management
Documentation
Technical Writing
Collaboration
Communication

Summary

Responsibilities:

Draft, update, and optimize QMS procedures to align with Code beamer upgrades, organizational standards, and regulatory requirements.
Collaborate with cross-functional Quality and R&D teams to ensure procedures accurately reflect best practices and compliance expectations.
Translate technical and regulatory requirements into clear, practical documentation for end users.
Support change management processes, ensuring procedural updates are properly controlled and communicated.
Ensure documentation is compliant with ISO 13485, 21 CFR Part 820, EU MDR, and internal quality system standards.
Partner with stakeholders to validate that documentation aligns with both product development processes and regulatory needs.

Requirements:

Proven experience in the medical device industry, with strong knowledge of QMS documentation and procedures.
Hands-on experience authoring and revising procedures compliant with ISO 13485, 21 CFR Part 820, and EU MDR.
Familiarity with Code beamer or similar ALM systems (e.g., Polariton, Jama, etc.).
Strong understanding of regulatory and product development processes across Quality Assurance and R&D.
Excellent technical writing, documentation, and organizational skills.
Ability to work independently, manage multiple priorities, and deliver within tight project timelines.

Preferred Qualifications:

Prior experience supporting system upgrades or documentation alignment projects.
Background in technical writing within regulated environments.
Strong collaboration and communication skills, with the ability to partner across functions.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 4cc263c7fd5d76dddadcba81822929b9
Posted 30+ days ago

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Remote or Minneapolis, Minnesota

•

Today

The role - what you'll do Barr is seeking a senior process engineer with demonstrated consulting experience to join our multi-disciplinary project teams serving manufacturing clients in the pharmaceutical and life sciences sector. The person in this position will play a key role in advancing our pharmaceutical services with new and existing clients by providing process engineering and technical expertise. This person will have opportunities to grow in project leadership and collaborate with mult

Full-time

USD 115,000.00 - 130,000.00 per year

Principal Process Mechanical / Wastewater Engineer

Remote or Tampa, Florida

•

Today

Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets. We are more than 36,000 people, in over 70 countries, dedicated to improving quality of life. Everyone has an important role to play. With the power of many curious minds, together we can solve the world's most complex challenges and deliver more impact together. Role description: Arcadis is looking for a Principal Process Mechanical / Wastewater Engineer

Full-time

USD 113,933.00 - 193,686.00 per year

Sr Engineer - PFS Platform and Lyo Kit

Remote or Thousand Oaks, California

•

Today

Career Category Engineering Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients ea

Full-time

USD 119,195.00 per year

Senior Software Test Engineer- Embedded Systems /Medical Devices (Hybrid)

Remote or Portage, Michigan

•

Today

Work Flexibility: Hybrid or Onsite The Senior Software Test Engineer - Embedded Systems/Medical Devices will be responsible for leading the verification and validation (V&V) of embedded software in our Class I, II, & medical devices. This role is critical to ensuring our products meet the highest standards of quality, safety, and regulatory compliance. The ideal candidate will bring deep expertise in embedded systems, test automation, and software testing within regulated environments (IEC 623

Full-time

Senior QMS Process Engineer

Dice Job Match Score™

Dice Job Match Score™

Job Details

Skills

Summary

Similar Jobs

Dice Job Match Score™