Design Quality Engineer Lead - MedTech, Regulatory
Mass Digital Health
Mass Digital Health is seeking a Design Quality Engineer in Bedford, MA to oversee the design control process, ensuring compliance with regulatory standards. The role involves leading process validation strategies, managing risk, and integrating quality insights into product development. The ideal candidate will have at least 5 years of experience in FDA regulated environments, focusing on design assurance and quality control. A Bachelor's Degree in a related field is required, and the position demands on-site work full-time. #J-18808-Ljbffr Mass Digital Health
$135k - $160k
...Job Description Manage the Design Control and product design... ...device product families. Provide Quality Engineering support for Product... ...&D, Operations, Commercial, Regulatory and Operations Quality to ensure... ...applicable requirements • Lead cross functional teams to implement...Regulatory$102.48k - $163.97k
Design Quality Engineer The Design Quality Engineer is responsible for the entire design control process... ..., and design transfer, as well as leading comprehensive process validation... ...and current portfolio meet quality and regulatory standards during production. Your role...RegulatoryFull timeWork at officeWork visaRelocation package3 days per week- Mass Digital Health is seeking a Design Quality Engineer in Bedford, MA. This role entails overseeing... ...transfer, ensuring quality and regulatory compliance. Key responsibilities include... ...developing process validation strategies, leading quality improvement projects, and...Regulatory
$82.08k - $164.16k
...Lead V&V QA Engineer - MedTech At Capgemini Engineering, the world leader in engineering... ...detail-oriented Software Quality Lead to ensure end-to-end... ..., inconsistencies, and regulatory alignment Ensure full... ...V&V activities Oversee design controls and ensure Design...RegulatoryPermanent employmentFull timeContract workLocal area- ...At Capgemini Engineering, the world leader in engineering services,... ...actively looking for Senior Design Quality Engineer with senior QA who... ...will be serving as the quality lead on product development teams... ..., ISO), and contributing to regulatory submissions (e.g., IDE, PMA,...RegulatoryPermanent employmentFull timeLocal area
$102.48k - $163.97k
...DESCRIPTION Job Title Software Design Quality Engineer Job Description The Software Design... ..., ensuring their accuracy and regulatory compliance throughout the software lifecycle. Your role: Leads the assessment of software designs by reviewing...RegulatoryFull timeWork at officeImmediate startWork visaRelocation package3 days per week- ...Job Description Description: The Design Quality Assurance Engineer is responsible for ensuring Design Control... ...design transfer — ensuring that all regulatory, customer, and internal quality... ...appropriately investigated and documented. Lead the quality aspects of design...RegulatoryContract workWork experience placementWork at office
$120k - $160k
...markets. About the role The Principal Design Quality Engineer I plays a central role in ensuring... ...with R&D, Systems Engineering, Regulatory Affairs, and Manufacturing to guide products... ..., and other applicable standards. Lead and maintain Design Control activities...RegulatoryHourly payWork at officeFlexible hours- ...alternative application process. Product Quality Engineer II 30+ days ago Requisition ID: 1880... ...quality system in accordance with applicable regulatory requirements. •Identify quality system... ...improvements and implement solutions. •Lead or assist with the Corrective Action/...RegulatoryWork at office
$61.3k - $122.7k
...spans the spectrum of healthcare, with leading businesses and products in... ...countries. Job Title Software Design Quality Engineer Working at Abbott At Abbott,... ...DHF content completion, integrity, and regulatory & standards compliance; collaboratively...RegulatoryFull timeFor contractorsWork experience placement- ...cardiac catheter. The Senior Quality Engineer will support sustaining... ...office. RESPONSIBILITIES Lead support for new product... ...product realization through design control phase activity including... ...processes to comply with regulatory standards Foster a culture...RegulatoryFull timeWork at office
$106.8k
...About the role The Principal Design Quality Assurance Engineer will bring their leadership to new product... ...which meet BSC, customer, and regulatory requirements. Work Mode At Boston... ...Your responsibilities include: Lead Quality function for product development...RegulatoryHourly payRelocation packageShift work3 days per week$102.48k - $163.97k
Process Quality Engineer The Process Quality Engineer is responsible for... ...associated controls in relation to design changes and assists in... ...conformance disposition management, leads analysis of defects for... ...initiatives and ensure regulatory compliance. Delivers specialized...RegulatoryFull timeWork at officeWork visaRelocation package3 days per week$90k - $100k
A leading manufacturing firm in Billerica seeks a Quality Engineer to ensure that products exceed customer expectations. Responsibilities include leading quality improvement projects, defining quality processes, and collaborating with internal teams. The role requires...$90k - $120k
...Quality Assurance Engineer Department: Quality Employment Type: Full Time... ...technology has been referred by leading-edge rehabilitation... ...Quality activities including design controls, V&V planning, QA... ...of ISO 14971 and ISO 13485 regulatory requirements. Minitab or...RegulatoryFull time$150k - $160k
...in imaging performance, innovative design, and uncompromising quality ensures our solutions consistently... ...is looking for a Sr. Software Test Engineer who are highly motivated, results-driven... ...details. Ensure all QMS and regulatory requirements are met. Participate...RegulatoryFull timeFlexible hours$105k - $130k
...for an experienced Senior QA Engineer to work on a variety of automation... ...and specifications; design comprehensive test cases and... ...issues. Collect and analyze quality metrics to evaluate the effectiveness... ...; ensure that software meets regulatory standards and industry best...RegulatoryWork at office$102.48k - $163.97k
Quality Systems Engineer Job Description The Quality Systems Engineer is responsible for ensuring an... ...ensuring that QMS is efficient and meets the regulatory requirements. Analyzes QMS metrics... ...of the area of specialization. Leads cross‑functional problem‑solving sessions...RegulatoryFull timeWork at officeWork visaRelocation package3 days per week- A leading technology firm in Billerica, MA is seeking a Jurisdiction & Classification Manager to oversee compliance with export... ...Bachelor's degree and a minimum of 5 years experience in engineering and regulatory analysis. Competitive salary offered, along with the...Regulatory
$135k - $160k
Access Vascular is seeking a Senior Designs Assurance Quality Engineer located in Billerica, Massachusetts. The role involves managing design control processes and providing quality engineering support for medical device product families. Candidates should have a BS in...- ...medical device complaints and ensure compliance with FDA and ISO regulations. The ideal candidate will have a Bachelor’s degree in Engineering or Life Sciences and at least 3 years of experience in complaint handling. Responsibilities include complaint intake, root cause...Regulatory
- ...seeking an Aseptic Manufacturing Manager to lead sterile drug and medical device... ...operations. You will ensure compliance with regulatory frameworks including FDA cGMPs and optimize operations for efficiency and quality. The ideal candidate brings over eight years...Regulatory
$130k - $160k
An opportunity for a Senior Software Quality Engineer based in Bedford, Massachusetts. The role requires leading quality assurance activities throughout the product lifecycle in compliance with regulations. The ideal candidate needs at least 8 years of relevant experience...Regulatory- ...Job Title: Quality Engineer Department: Quality Reports To: Quality Manager... ...machined products meet strict customer and regulatory requirements. The ideal candidate... ...Haverhill, MA facility. What Youll Do Lead incoming, in-process, and final...RegulatoryFull timeWork at office
- PharmaEssentia U.S.A. is seeking an Associate Director, Regulatory, to lead compliance-focused regulatory reviews of promotional materials. This role involves ensuring that promotional content adheres to FDA and FTC standards and managing submissions for promotional materials...RegulatoryFixed term contract
$160k - $200k
Overview The Principal Compliance Engineer is the Hemostasis and Acute... ...This individual works with Regulatory and Quality departments to keep the... ...Accountabilities Establish, maintain, and lead EMI/EMC and Electrical... ...applicability guidance, and design/test expectations aligned to...RegulatoryWork experience placement- Werfen is offering a position focused on ensuring regulatory compliance for digital health products in Bedford, MA. The ideal candidate... ...teams on regulatory requirements, authoring regulatory plans, and leading regulatory submissions. The role involves working closely with...Regulatory
$105k - $130k
Werfen is seeking a Regulatory Affairs professional to ensure compliance for digital health products. This role involves advising teams on regulatory requirements, authoring regulatory documentation, and ensuring product compliance with domestic and international regulations...Regulatory- Werfen is seeking an experienced regulatory professional to ensure compliance with domestic and international regulations for digital health products. The successful candidate will work independently and participate in software development meetings, prepare regulatory...Regulatory
$90k - $130k
Envision Energy in Burlington, MA is looking for a Quality Engineer to develop and implement quality system functions for water electrolyzer product development. The successful candidate will manage the quality management system, work with various teams, and enforce product...
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