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
...dedication to innovation and quality. We’re passionate about... ...of the Quality Management System (QMS), while ensuring compliance to GMP requirements, FDA & ISO standards, and other regulations... ...Key Accountabilities Senior Quality Systems Specialist I will be expected to...SeniorWork at officeRemote workWorldwide- ...around the world. The Role: The Quality System Specialist/Senior Quality System Specialist plays a... ...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...SeniorWork experience placement
$94k - $111k
...laboratory QA staff (advisor) ensures compliance to GLP, GCLP (ISO/IEC 17025), GRLP and other GxP... ...support the implementation of GLP/GCLP quality initiatives, systems, and processes across the relevant... ...of the following: R&D Quality (GMP or GLP) and/or product development...SeniorLocal area$100k - $125k
MapLight Therapeutics, Inc. seeks a Quality System Specialist to support the development of biotech products. This hybrid role requires strong... ...controlled documents, supporting QA onboarding, and adhering to compliance standards. Compensation ranges from $100,000 to $125,000...Suggested$100k - $125k
MapLight Therapeutics, Inc. is seeking a Quality System Specialist to support the development and manufacturing of products. This role involves... ...systems, managing controlled documentation, and ensuring compliance with regulations. The ideal candidate has a Bachelor's in...Suggested- 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
- Actalent is seeking a dedicated Quality Assurance Specialist in Bedford, MA, to manage and oversee quality and compliance activities in accordance with cGMP, FDA, and ISO standards. The role involves... ...have 3-5 years of experience in GMP and FDA environments. Benefits...
$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...Local areaWorldwide3 days per week$100k - $125k
...discovery for central nervous system disorders. We combine... .... What You’ll Do The Quality System Specialist will support the... .... Reporting to the Senior Manager, Quality Systems... ...role in supporting the GMP Quality Management System to ensure compliance with applicable GxP...Temporary workFor contractorsWork experience placementWork at officeFlexible hours3 days per week$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- Vericel® Corporation is seeking a QA Validation Specialist in Burlington, MA to manage validation activities ensuring compliance with cGMP regulations. You will have... ...qualifications, and overseeing maintenance of validated systems. The ideal candidate holds a Bachelor's or...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
$123k - $166k
...Senior Quality Assurance Specialist Wave Life Sciences is a biotechnology company focused... ...working in or with a GMP organization ~ Experience... ...QMS, LIMS, ERP and other systems ~ Experience with batch... ...other documentation to ensure compliance to GDPs and governing SOPs...SeniorTemporary workWork experience placementSummer workLocal area- ...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
$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- Michael Page is seeking a Quality Manager based in Burlington, Massachusetts. This role involves leading the Quality Management System in a high-tech manufacturing environment while driving... ...or Management. Strong knowledge of ISO 9001 and proven leadership skills are essential...Senior
$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$50k - $60k
...us to quickly deliver high-quality biospecimens and reliable,... ...company’s Quality Management System and ensuring compliance with regulatory... ...Good Laboratory Practice, ISO 9001. A Day in the... ...and ensure compliance with GMP and ISO standards Participate...Monday to Friday- 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
$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- ...Therapeutics is looking for a Senior Site Plumber based in Bedford,... ...oversees plumbing operations for a GMP manufacturing facility,... ...reliability of critical utility systems. Candidates should have a High... ...junior technicians, and leading compliance initiatives. Anika offers...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
$93k - $110k
...QA Validation Specialist At Vericel Corporation, we... ...and utilities, ensuring systems remain in a validated... ...validated systems and product quality. Participate in... ...ensure accuracy and compliance with product... ...classified manufacturing ISO 7 clean room areas, to...SeniorFor contractorsShift work$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- ...Senior Systems Engineer Raytheon is a world leader in high altitude imaging sensors. As such, we in the Advanced Product Solutions department provide the United States Government and International Partners with remote sensing systems, for time critical intelligence...SeniorContract workWork experience placementWork at officeRemote workRelocationDay shift
$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$128k - $177k
Overview SHINE SPECT is seeking a Quality & Lab System Administrator who will be responsible for the... ...to ensure optimal performance and compliance with laboratory standards. Manage user... ...with regulatory requirements (e.g., FDA, GMP, GLP) in system configuration and data...2 days per week3 days per week- ...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
- 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
- ...defense, factory automation, air and water quality environmental monitoring, electronics... ...Job Summary: Seeking a talented Senior or Principal Systems Engineer (depending on years of... ...and manage requirements tracking and compliance through design and test phases. Translate...SeniorMinimum wageWork experience placementWork at officeLocal area
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