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

Quality Manager-ISO 13485/Medical Devices

Reedsville, Pennsylvania

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Today

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.

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Third Party, Contract

52 - 60

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

Bedford, Massachusetts

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14d ago

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

Quality engineer / Lead/ Manager - Medical Devices Manufacturing Experience

Reedsville, Pennsylvania

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5d 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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Third Party, Contract

Depends on Experience

Quality Engineer Medical Device

Reedsville, Pennsylvania

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Today

Key Responsibilities Lead manufacturing quality assessments, audits, and remediation. Drive FPY improvement, defect reduction, and quality metrics. Review IQ/OQ/PQ, TMV, SPC, MSA, PFMEA, and process risk activities. Manage CAPA, nonconformance, and supplier quality issues. Support FDA, ISO 13485, MDSAP, and regulatory audits. Required 8+ years of medical device manufacturing quality experience. Strong Manufacturing Quality Engineering background. Experience with Class II/ medical devices. Hands-

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Third Party, Contract

50 - 60

Quality engineer

Reedsville, Pennsylvania

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6d 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

Regulatory & Clinical Affairs Manager

Princeton, New Jersey

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4d ago

Regulatory & Clinical Affairs Manager Princeton, NJ Permanent Qualifications: Bachelors degree in engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, or related field. 5-12 years of experience in medical device regulatory affairs. Hands-on experience on FDA, CE, EU MDR submissions - candidates themselves shall still be active in preparing the submissions, rather than serving only in a managerial or oversight capacity Experience with Software as a Medical Device (SaMD)/Si

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Full-time

Depends on Experience

Medical Device Quality Manager

Reedsville, Pennsylvania

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6d 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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Contract, Third Party

Depends on Experience

Supplier Quality Engineer

El Paso, Texas

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19d 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

DevOps and Mobile Operations

Plano, Texas

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Today

Position: DevOps and Mobile Operations Location : Plano, TX About the Role We are looking for a self-driven, highly organized Senior Software Engineer who combines strong software development skills with technical leadership and consistent follow-through. You will create software and scripts, lead DevOps and CI/CD improvements, coordinate mobile product launches, and investigate complex field issues across connected systems. AI-enabled engineering is central to this role and will be used respon

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Third Party, Contract

60 - 65

Software Quality Validation Engineer (Medical Devices) - Only On W2

Pleasanton, California

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5d ago

Major Duties Support software verification & validation (V&V) activities (test protocols, plans, reports), including non-product software assessment. Support product cybersecurity assessments in collaboration with cross-functional teams. Review software and system documentation to ensure quality and compliance. Maintain requirements traceability and support SDLC processes. Perform risk assessments (FMEA, hazard analysis) and drive issue resolution. Participate in sustaining engineering act

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Contract

35 - 40

Electro-Mechanical LCM Engineer

Hybrid in Irvine, California

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19d 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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Today

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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Third Party, Contract

32 - 36

Validation Engineer

Boston, Massachusetts

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17d ago

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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19d 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

Electrical Engineer

Durham, North Carolina

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14d ago

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

Quality Lead

Reedsville, Pennsylvania

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Today

Role: Quality Lead Location: Reedsville, PA (Day 1 Onsite) Job Summary: Support quality remediation and compliance initiatives by managing nonconformance, CAPA, deviation, complaint handling, and quality system activities. Perform quality assessments, root cause investigations, data analysis, and quality improvement initiatives while ensuring compliance with medical device regulations and standards Key Responsibilities: Manage CAPA, Nonconformance, and Deviation activities. Conduct Root Cause A

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Full-time, Part-time, Contract, Third Party

Senior Validation Engineer

Rochester, New York

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17d ago

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

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