Senior Quality Systems Specialist I - GMP/ISO Compliance
$115k - $140kWerfen
A medical diagnostics company in Bedford, MA is looking for a Senior Quality Systems Specialist I to oversee compliance with quality management systems. The role involves managing CAPA processes, facilitating audits, and supporting training programs. Ideal candidates will have 8+ years in the medical device sector and a bachelor's degree in science or engineering. The position is predominantly onsite with some remote flexibility and offers a competitive salary range of $115K to $140K. #J-18808-Ljbffr Werfen
$115k - $140k
...improvement of key components of the Quality Management System (QMS), while ensuring compliance to GMP requirements, FDA & ISO standards, and other regulations as... ...Accountabilities Essential Functions: The Senior Quality Systems Specialist I will be expected to support all...SeniorWork at officeRemote work$60k - $110k
Quality System Specialist/Senior Quality System Specialist Terrestrial (formerly known as Vaxess) is... ...System (QMS) to ensure compliance with applicable GMP/GLP standards. This position focuses... ...standards (21 CFR Parts 210/211/11/820; ISO 9001/13485). ● Excellent...Senior$186k - $200k
...Pharmaceuticals is seeking an Assoc. Director, Quality to lead GMP technical transfer activities from... ...to commercial manufacturing, ensuring compliance with regulatory requirements and... ...experience and a strong background in quality systems. Responsibilities include providing...Senior- A leading global diagnostics company seeks a Senior Quality Systems Specialist I in Bedford, MA. This role involves enhancing and monitoring the Quality Management System. Responsibilities include implementing CAPA processes, conducting internal audits, and maintaining...Senior
$89k - $148k
...coordinating Annual Product Quality Reports (APQR),... ...quality management system. Other functional... ...Reports (PMSR) to senior management for... ...Review documents for compliance with regulatory guidelines... ...of cGMP, ICH, ISO 13485, ISO 14971,... .../or medical device GMP compliance regulatory...SuggestedLocal areaWorldwide3 days per week$30 - $32 per hour
JMD Technologies Inc. is looking for a Quality Assurance Specialist in Bedford, Massachusetts. The role supports QA and manufacturing by ensuring compliance with GMP, FDA, and ISO standards. Responsibilities include reviewing batch records, performing product release,...Hourly pay- ...New England Donor Services is seeking a Quality Systems Specialist I to ensure compliance with regulatory requirements in a hybrid role. This position involves performing QA reviews of donor records and collaborating with team members. The ideal candidate will have experience...
- ...Kiniksa Pharmaceuticals is seeking an Associate Director, GMP Quality Assurance Operations in Lexington, MA to oversee quality operations... ...the manufacturing process, including tech transfers and compliance with global regulatory standards. The ideal candidate will have...Senior
$115k - $140k
Werfen is looking for a Senior Quality Systems Specialist I in Bedford, MA, responsible for assisting in the planning and improvement of the Quality Management System while ensuring compliance with GMP, FDA, and ISO standards. The role involves supporting internal audits...Senior- The Quality Assurance (QA) Associate II supports and assists... ...the Quality and Compliance program within Broad Clinical... ...the Quality Management System (QMS). This role... ...including CLIA, CAP, CLEP, and ISO 9001, while promoting a... ...(e.g., ISO 9001, GCLP, GMP) preferred...Local areaFlexible hours
$30 - $32 per hour
...manufacturing operations by ensuring compliance with GMP, FDA, and ISO requirements through batch record... ..., product release, and on-the-floor quality support. Key Responsibilities Review... ...improvement of the Quality Management System. Qualifications Experience in GMP-...Hourly payWork at office- Senior Quality Lab Specialist Bedford, MA Quanterix is a global leader in ultra-sensitive... ...will ensure regulatory compliance, lead audits, and drive... ...of our Quality Management System. This position will be onsite... ...compliance with CLIA regulations, ISO 15189, and GCLP guidelines...Senior
- A global leader in diagnostics is seeking a Senior Quality Systems Specialist to maintain and improve Quality Management Systems. Located in Bedford, MA, the role focuses on compliance with FDA and ISO standards, involving CAPA, internal audits, and training programs. Candidates...Remote work
$105k - $130k
...guidance from management or senior regulatory staff, the... ..., and promoting compliance with global digital health... ...international regulatory/quality standards related to... ...compliance Knowledge of FDA, ISO, MDSAP and... ...requirements and understanding of GMP Language: English...SeniorLocal area$275k - $315k
...enterprise-level leadership of GMP Quality and Quality across GxP... ...integrated Quality Management System (QMS). Lead a team of subject... ...Strategic leader on the Quality and Compliance Leadership Team to represent... ...escalate compliance risks to Senior Management. Ensure audit...SeniorContract work- ...manufacturer located in Massachusetts is searching for a Site Quality Manager to oversee all quality functions. The successful candidate will manage the Quality Management System ensuring compliance with AS9100 and ISO 9001. This role involves leading a team to drive...Senior
- Welfab Inc is seeking a Quality Manager based in North Billerica, MA, to lead the ISO 9001 Quality Management System. The ideal candidate will have over 5 years of experience in precision manufacturing, manage a team of Quality Technicians, and drive continuous improvement...Senior
$50k - $60k
...us to quickly deliver high-quality biospecimens and reearch products... ...’s Quality Management System and ensuring compliance with regulatory... ...Good Laboratory Practice, ISO 9001. A Day in the Life... ...and ensure compliance with GMP and ISO standards Participate...Monday to Friday$82.01k - $113.3k
...leading biotechnology company is seeking a Senior Laboratory Operations Associate in... ...focusing on high-throughput chemistry and GMP. The ideal candidate will manage laboratory... ...handle high-hazard chemicals, and ensure compliance with safety protocols. The position offers...Senior- NOVA Biomedical GmbH is seeking a Senior Quality Engineer to enhance quality practices across product... ...processes. You will oversee quality systems, manage internal audits, and support... ...candidate will have a solid understanding of ISO standards and FDA regulations, along...Senior
$9k
Modern Technology Solutions, Inc. (MTSI) is seeking a Senior Cyber Security - Information Systems Security Manager (ISSM) in Dayton, OH or Hanscom AFB. As a Senior Cybersecurity Engineer / Information Systems Security Manager (ISSM) with MTSI you will support a customer...SeniorFull timeWork at officeLocal areaImmediate startWorldwideFlexible hours$20 - $26.92 per hour
# HIM Quality Control SpecialistBurlington, MA • Beth... ...Quality Control Specialist provides continuous quality... ...Management (HIM) regulatory compliance.**Job Description:**1.... ..., utilizing computer systems.Skills, Knowledge &... ..., that may include seniority, education, training,...Hourly payFull timeWork at officeShift work- A leading engineering firm is seeking a Senior Environmental Compliance Specialist / Environmental Scientist to support environmental compliance programs... ...projects, developing procedures, and ensuring compliance with ISO 14001. This position requires travel up to 50% of the...Senior
- ...Manager/AD, Clinical Data Management & Systems Join Apex Systems as a strategic data leader... ...collaboration to deliver high‑quality insights that shape clinical development... ...Oversee EDC systems and ensure GCP/GCDMP compliance Collaborate with Biostats, Clinical Ops,...Senior
- Apogee Engineering is seeking a Modernization Systems Engineer to provide engineering support for the Ground-Based Radar Digitization... ...processes, reviewing contractor plans, and ensuring compliance with Government objectives. The ideal candidate will have extensive...SeniorFull timeFor contractors
$28.85 - $34 per hour
...tasks including batch record review, label issuance, and inspection of final products within an ISO 7 cleanroom. Candidates with a High School degree/GED and essential GMP knowledge are preferred, with an hourly wage ranging from $28.85 to $34. The role emphasizes teamwork...Hourly pay- Quality Specialist/Technical Writer page is loaded## Quality Specialist/Technical... ...programs to ensure quality system readiness for external and internal audits and compliance with industry regulations and... ...industry regulations (e.g., ISO, GMP) related to documentation*...Minimum wagePermanent employmentWork experience placementWork at officeLocal areaShift work
$135k - $160k
...device product families. Provide Quality Engineering support for... ...Operations Quality to ensure compliance with AVI's QMS and FDA QMSR requirements... ...in accordance with FDA, ISO and other applicable... ...Analysis (RCA), Measurement Systems Analysis (MSA) & Gage Repeatability...Senior- ...General Summary of Position: The Senior Business Systems Analyst (Document Management Systems) is a key member of the Enterprise Applications... ...of data governance, information security, and compliance principles ~ Strong written and verbal communication skills...SeniorFull timeWork at officeImmediate start
$130k - $180k
...Johnson Controls, Inc. is seeking a Senior Principal Electronics Engineer to develop electronic products for safety systems. This role is part of a leading R&D team. Applicants should have 10+ years in electronic product development and strong project management skills...Senior
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