ISO 13485 jobs | Dice.com

Quality Manager - Medical Device/ ISO 13485

Salem Lakes, Wisconsin

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Today

Description: Quality Manager | ISO 13485 Medical Device Manufacturing We are seeking a hands-on Quality Manager who can lead and continuously improve our ISO 13485 Quality Management System while supporting a fast-paced medical device packaging manufacturing operation. This individual will serve as the site quality leader, partnering closely with Operations, Engineering, Supply Chain, and Customer Service to ensure compliance, drive continuous improvement, and maintain customer confidence. The

Full-time

USD 95,000.00 - 125,000.00 per year

Sr. Supplier Quality Engineer (ONLY W-2 role)

Bedford, Massachusetts

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Today

Position Title: Sr. Supplier Quality Engineer (PHIAJP00004186) Location: Bedford MA Duration: 12 months Positions Requested: 2 Hours per Week: 40 (8 hrs/day) Notes from the manager: Major focus in experienced Process Validation, Verification across plastic, metal and electronics along with problem solving for candidates to support +700 parts for part qualification for Spectrawave products. The product contains Catheter and Console (System) products. Manufacture engineering, Product Quality, and/

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Contract

50 - 55

Senior Quality Analyst (Technology Analyst - US) @ Salt Lake City, UT 84116 (should be in Utah) - Only on W2

Hybrid in Salt Lake City, Utah

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Yesterday

Role: Senior Quality Analyst (Technology Analyst - US) Location : Salt Lake City, UT 84116 (should be in Utah) Experience: 6-12 yrs Duration: Long Term Only on W2 Please share the resume at Must have skills: 1. Medical devices 2. Medical Device Quality Engineering 3. Manufacturing Quality 4. Root Cause Analysis and CAPA 5. SPC / Process Capability Analysis 6. PFMEA and Control Plans 7. Plastics Manufacturing and Injection Molding 8. Assembly and Labeling Processes 9. FDA and ISO 13485 regulated

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Contract

$40 - $50

Quality engineer / Lead/ Manager - Medical Devices Manufacturing Experience

Reedsville, Pennsylvania

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7d ago

Role: Quality engineer / Lead/ Manager Medical Devices Manufacturing Experience Positions: 5 Openings Location: Reedsville, PA (Day 1 Onsite) Job Summary: Lead manufacturing quality assessment, remediation, and continuous improvement initiatives for Class II/ medical devices. Evaluate manufacturing processes, process validations, risk management activities, supplier quality systems, and compliance to FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and MDSAP requirements. Drive yield

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Contract, Third Party

Depends on Experience

Quality engineer

Reedsville, Pennsylvania

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8d ago

Job Summary: Lead manufacturing quality assessment, remediation, and continuous improvement initiatives for Class II/ medical devices. Evaluate manufacturing processes, process validations, risk management activities, supplier quality systems, and compliance to FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and MDSAP requirements. Drive yield improvement, CAPA effectiveness, quality metrics review, and manufacturing risk reduction programs across regulated manufacturing environments. Key Resp

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Contract, Third Party

55 - 60

Medical Device Quality Manager

Reedsville, Pennsylvania

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8d ago

Job Summary: Lead quality remediation and compliance programs for medical devices, ensuring adherence to FDA, ISO 13485, and global regulatory requirements. Provide leadership for QMS processes, audit readiness, CAPA governance, quality metrics, and continuous improvement initiatives across cross-functional teams. Key Responsibilities: Lead QMS, CAPA, Nonconformance, Complaint, and Audit programs.Support FDA inspections and regulatory audits.Drive quality remediation and compliance initiatives.M

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Third Party, Contract

Depends on Experience

Supplier Quality Engineer

El Paso, Texas

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21d ago

The SQE will lead supplier quality initiatives, supplier qualification activities, investigations, corrective actions, audits, and risk management efforts to support business continuity and product quality. Job Responsibilities: Supplier Quality Management Collaborate with suppliers and internal business partners to ensure robust materials, products, processes, and quality systems. Manage supplier quality performance through data analysis, trend monitoring, and risk assessment activities. Identi

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Contract

Depends on Experience

Software Test Automation Engineer

Hybrid in Plymouth, Minnesota

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Today

Job Title: Software Engineer - Medical Imaging (Plymouth, MN) Remote: Hybrid - 3 days in office. Any three days is OK. This is up to the worker. Tues, Wed and Thurs is pretty consistent with the other workers on our team.. Interview process - Video with mgr (45 min) then have tech interview with techs (2 techs, 45 min video) Software Test Automation Engineer As a Software Test Automation Engineer, you will join a high-performing, global, cross-functional Scrum team within the Image Guided Thera

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Contract

40 - 60

Electro-Mechanical LCM Engineer

Hybrid in Irvine, California

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20d ago

Responsibilities will include: Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design to ensure parts, equipment, tools, fixtures, etc. are up to standards Use technical principles, problem solving skills, and data analysis to support and problem-solve for production at contract manufacturer. Work and lead initiatives to support ma

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Contract

Depends on Experience

Manual QA with Healthcare Experience

Remote

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Yesterday

Title -Manual QAwith Healthcare Experience Location:Dallas, TX (Hybrid - Onsite) Work Type: W2/C2C/1099 Contract Experience: 5 Years of experience candidate Job Description:We are looking for a SeniorQAEngineer with deep expertise in healthcare processes and AI driven applications. This role is critical in ensuring the safety, accuracy, and compliance of our healthcare-focused AI products. The ideal candidate will have a strong background inQAmethodologies (bothmanualand automatedtesting, buildi

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Contract, Third Party

32 - 36

Validation Engineer

Boston, Massachusetts

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Today

Job Summary: We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products. The role involves planning and executing V&V activities, developing and executing validation protocols, supporting design verification, and ensuring compliance with FDA, ISO 13485, and internal quality system requirements. Experience with infusion pump systems or similar electromechanical medical devices is preferred. Roles & Responsibilit

Full-time

Quality Engineer

El Paso, Texas

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21d ago

The Quality Engineer is responsible for providing quality engineering support to manufacturing operations and quality systems to ensure products are manufactured in compliance with applicable regulatory requirements, quality standards, and company procedures. The Quality Engineer serves as a technical resource for process improvement, investigations, validations, risk assessments, and quality system activities while supporting the manufacture of safe and effective products that meet customer and

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Contract

Depends on Experience

Senior Validation Engineer

Rochester, New York

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Today

Summary: We are seeking a highly skilled R&D/Validation Engineer with mandatory experience in the Medical Devices domain. The ideal candidate will be responsible for planning, leading, and coordinating project execution and validation activities in strict alignment with ISO 13485 and ISO 14971 standards. This role requires a hands-on leader who can manage equipment, process, and product transfers while liaising with global teams and customers to ensure on-time delivery. Roles & Responsibilities:

Full-time

Automation Engineer II

Bedford, Massachusetts

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description How will you make an impact? The job of the Automation Engineer II is to maintain and troubleshoot all process controls. This role primary function is to address all issues that occur on the plant floor and to escalate any c

Full-time

USD 72,600.00 - 108,900.00 per year

Electrical Engineer

Durham, North Carolina

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Today

Position Title: Electrical Engineer - Contract Location: Durham, NC - Onsite Duration: 12-Month Contract Hours: 40 hours per week Interview Process: (Virtual/Onsite) 2-Round Interview Process (Virtual/onsite) Ideal Start Date: Late August Background Check Required Scope of Work: This Role will be responsible for the design, development, and testing of electrical systems and components for medical device products. You will contribute to various stages of the product lifecycle, from concept thr

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Contract

$58 - $68

Mechanical Engineer

Foxborough, Massachusetts

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Today

Dear Candidate, My name is Manisha Singh and I am a recruiter at Stellent IT LLC. I am reaching out to you on an exciting job opportunity with one of our clients. Should you be interested, please send me a copy of your resume in word format along with your LinkedIn URL. We have a Mechanical Engineer role that is full time if you are interested. Need American born s no job shoppers. Candidates need to have a LinkedIn Profile as well. Vertical is Medical Device Mechanical Engineer - Medical Dev

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Full-time

Systems Engineer - Health Software

San Diego, California

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Today

Make a Life-Changing Impact Ready to improve the lives of millions of people around the world by helping Apple ship regulated health features that users rely on every day? Description As a Systems Engineer in Health Software, you'll be at the intersection of innovation and regulation - seeing the big picture across regulated projects, connecting teams and disciplines, and doing work that genuinely matters. We're a small team that values collaboration, each other, and quality, and we're lookin

Full-time

Staff Engineer, Quality

Waltham, Massachusetts

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Today

Work Flexibility: Onsite Join Stryker's Amplitude Vascular Systems (AVS) team in Waltham, Massachusetts as a Staff Quality Engineer. In this role, you will support manufacturing operations, supplier quality, and process performance across both existing and new products. Working closely with operations, engineering, suppliers, and cross-functional partners, you will help ensure products and manufacturing processes meet quality standards, regulatory requirements, and customer expectations. This

Full-time

USD 107,200.00 - 178,600.00 per year

Associate Quality Engineer

California

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Today

Associate Quality Engineer - Contract - Johns Creek, GA - $25.00 - $29.15/hr The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position. Applicants must be legally authorized to work in the United States. Sponsorship not available. Our client is se

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Contract

USD 25.00 - 29.15 per hour

Service Quality Engineer

Gainesville, Florida

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Today

Job Title Service Quality Engineer Job Description In this role you Service Quality Engineers help bridge the gap between quality management systems (QMS) and service delivery, ensuring that customer needs, regulatory requirements, and internal standards are met. Your role: Quality Management System (QMS) Support: Facilitate and manage QMS activities across departments, sites, and businesses. Process Improvement: Lead or participate in initiatives to improve service and delivery processes, o

Full-time

USD 92,000.00 - 130,000.00 per year