CrawlJobs Logo

Sr. Quality Engineer

bhsg.com Logo

Beacon Hill

Location Icon

Location:
United States , Buford

Category Icon
Category:
IT - Administration

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

130000.00 - 149000.00 USD / Year
Save Job
Save Icon
Apply Position

Job Description:

In this critical role, you’ll provide quality oversight and technical leadership for radioisotope development programs, process scale-up, and commercial production operations. Your work will directly support Drug Master Files (DMFs) and pharmaceutical supply chains, ensuring compliance with cGMP and ISO standards while contributing to therapies that improve and extend lives.

Job Responsibility:

  • Ensure compliance with 21 CFR Parts 210 and 211 and/or 21 CFR Part 212 where applicable to radioisotope production activities
  • Support implementation and maintenance of quality systems consistent with pharmaceutical cGMP requirements
  • Provide quality oversight for radioisotope production, purification, packaging, and distribution processes
  • Participate in internal audits and regulatory inspections
  • Develop, review, and approve SOPs, batch production records, validation protocols, qualification documentation, and technical reports
  • Ensure production and development documentation complies with data integrity and recordkeeping requirements
  • Support development and maintenance of master batch records and production documentation
  • Lead or support validation and qualification activities for radioisotope production processes
  • Develop and execute validation protocols
  • Support qualification of production equipment, hot-cell systems, and laboratory instrumentation
  • Generate and review validation reports
  • Provide quality input into the preparation and maintenance of Drug Master Files (DMFs)
  • Conduct risk assessments and hazard analyses
  • Investigate deviations, nonconformances, and out-of-specification events
  • Perform root cause analysis and implement corrective and preventive actions (CAPA)
  • Work closely with radiochemistry and cyclotron operations teams
  • Provide quality oversight during technology transfer
  • Support continuous improvement initiatives

Requirements:

  • Bachelor’s degree in chemistry, Chemical Engineering, Biomedical Engineering, Radiochemistry, Pharmaceutical Sciences, Biological Sciences, or related field
  • A Minimum of 5 years of experience in quality engineering, quality assurance, or validation within regulated environments
  • Experience working with radioisotope production, radiochemistry, pharmaceutical manufacturing, or nuclear materials is REQUIRED
  • Experience supporting Drug Master File (DMF) submissions or pharmaceutical regulatory filings preferred
  • Experience supporting process validation, equipment qualification, and GMP documentation
  • Strong knowledge of cGMP and regulated quality systems (FDA, ISO, pharmaceutical, or medical device)
  • Working knowledge of radiochemistry, radioisotope production, or nuclear materials handling preferred
  • Experience with risk management methodologies, deviation investigations, and CAPA systems
  • Strong technical writing and documentation skills supporting regulated manufacturing environments
  • Ability to translate development activities into compliant production documentation and regulatory support packages
  • Strong project management and cross-functional communication skills
  • Proficiency with Microsoft Office and electronic quality management systems

Nice to have:

  • Experience supporting Drug Master File (DMF) submissions or pharmaceutical regulatory filings
  • Working knowledge of radiochemistry, radioisotope production, or nuclear materials handling
What we offer:
  • Career growth opportunities
  • Work on innovative projects with real patient impact
  • Collaborative, mission-driven culture
  • Competitive benefits package

Additional Information:

Job Posted:
May 15, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Icon
Beacon Hill - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Sr. Quality Engineer

Sr. Supplier Quality Engineer

Hunter Douglas is searching for a Sr. Supplier Quality Engineer. The role leads ...
Location
Location
Mexico , Monterrey
Salary
Salary:
Not provided
hunterdouglas.com Logo
Hunter Douglas
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree, Textiles or Motorization preferred
  • 5+ years of experience as SQE in the Blinds and Shades or Automotive Industry
  • Excellent communication skills
  • Must have the ability to self-manage
  • Results-oriented and roll-up-your-sleeves attitude
  • Strong Problem Solving
  • Details Oriented
  • Ability to deliver assignments in a dynamic environment
  • Training and developing SQEs
  • Advanced conversational English
Job Responsibility
Job Responsibility
  • Lead supplier on-site assessments and action planning/follow up prior to source selection
  • Lead supplier training and development activities
  • Define and document PPAP (Production part approval process) for new purchased components and major changes to existing components
  • Identify and lead projects to drive the external failure rates and internal defect rates down for assigned components
  • Supporting the HDNA-Procurement Team in the evaluation and selection, and approval of suppliers through the application of the PPAP methodology
  • Identify Chronic Supplier Quality issues through Fabrication/Manufacturing lines, Incoming Inspection, and Supplier Quality audits, and coordinate the resolution of those issues
  • Communicate company quality, delivery & service expectations to suppliers and partner effectively with them to develop quality systems, processes, and controls
  • Representing the organization as the primary supplier liaison on component and/or Finished Goods quality issues, ensuring supplier corrective actions are timely and effective (SCARs)
  • Monitoring, analyzing, and identifying trends from supplier quality and performance data, and developing proactive measures to continually improve performance
  • Supporting component and or Finished Goods development specifications, quality acceptance standards, and ensure new or changed purchased parts meet Hussmann specifications
What we offer
What we offer
  • Competitive compensation package including annual bonus
  • Generous benefits package including major medical expenses and life insurance
  • Vacation days
  • Vacation premium
  • Paid time off
  • Christmas bonus
  • Food vouchers and cafeteria service
  • Savings fund
  • Career developmental opportunities
  • A company culture that prioritizes internal development
  • Fulltime
Read More
Arrow Right

Sr. Quality Automation Engineer

The PC/FLex team is seeking a Sr Quality Automation Engineer who thrives in a ch...
Location
Location
United States , Aguadilla
Salary
Salary:
Not provided
https://www.hpe.com/ Logo
Hewlett Packard Enterprise
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BS/MS degree in Science or Engineering from a recognized and accredited university/college
  • at least 5+ years of relevant experience in developing and supporting automation test frameworks from ground up
  • knowledge of complete SDLC and experience in software testing methodology, tools, test planning and test execution
  • strong coding skills in Python & Playwright
  • strong troubleshooting and analytical skills for performing root cause analysis
  • ability to effectively work with stakeholders in multiple engineering teams for defect investigation, root cause analysis, and implementation of corrective/preventative actions
  • knowledge of tools and processes for regression, scale, and performance testing
  • experience working in continuous integration and continuous delivery
  • self-motivated with excellent verbal and written communication skills
  • experience in virtualization technologies
Job Responsibility
Job Responsibility
  • Understand, participate, provide input for functional and design specs and other design documentation
  • execute and automate long running, scale, reliability, and security testcases and report the results
  • collaborate with other cross-functional teams including but not limited to Product Management, Customer Support and Platform engineering
  • provide guidance and mentoring to new hires joining the team.
What we offer
What we offer
  • health and wellbeing benefits
  • personal and professional development programs
  • inclusive work environment.
  • Fulltime
Read More
Arrow Right

Sr. Engineer II, Software Engineering FE

At CVS Health, we’re building a world of health around every consumer and surrou...
Location
Location
United States , Chicago
Salary
Salary:
148949.00 - 180000.00 USD / Year
https://www.cvshealth.com/ Logo
CVS Health
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in Computer Science, Computer Engineering, or related field
  • six (6) years of progressively responsible, post-baccalaureate experience in a related occupation
  • Experience in building consumer-facing products using any SPA frameworks (React/Vue)
  • Experience in design first approach to software development
  • Experience in writing Jest / Vitest Unit Tests and achieving close to 100% code coverage
  • Experience working in an Agile/Devops environment
Job Responsibility
Job Responsibility
  • Contribute to all aspects of SDLC process (SCRUM, Design, Code, Test, Deploy & Maintain)
  • Collaborate with Product, UX and other Engineering teams
  • Collaborate with Platform team following Architecture best practices for scalability and reliability
  • Contribute to code review process to improve code quality
  • Mentor Engineers
  • Implement SecDevops best practices
  • and other duties as assigned
What we offer
What we offer
  • Full range of medical, dental, and vision benefits
  • 401(k) retirement savings plan
  • Employee Stock Purchase Plan
  • Fully-paid term life insurance plan
  • Short-term and long term disability benefits
  • Well-being programs
  • Education assistance
  • Free development courses
  • CVS store discount
  • Discount programs with participating partners
  • Fulltime
Read More
Arrow Right

Digital S/W Engineer Sr Analyst

The Digital S/W Engineer Sr Analyst is a seasoned professional role. Applies in-...
Location
Location
Mexico , Ciudad De Mexico
Salary
Salary:
Not provided
https://www.citi.com/ Logo
Citi
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 5-8 years in a product development/product management environment
  • Strong analytical and quantitative skills
  • Data driven and results-oriented
  • Experience delivering with an agile methodology
  • Experience in affecting large culture change
  • Experience leading infrastructure programs
  • Skilled at working with third party service providers
  • Excellent written and oral communication skills
  • Bachelor’s/University degree or equivalent experience
Job Responsibility
Job Responsibility
  • Accountable for executing and driving mid-size feature application design and development efforts to completion
  • Serving as a development lead on medium-scale projects and supporting the execution of larger efforts
  • Proficient at operating with considerable autonomy and discretion
  • Capable of research in root cause of development and performance concerns as well as the resolution of defects
  • Have a deep understanding of the technical requirements for the solutions being built
  • Understand engineering needs including those required to build, maintain, and operate the system through all phases of its life
  • Proficient in information modeling, data structures and algorithms
  • Understand maintenance characteristics, runtime properties and dependencies that exist in support of your system’s software
  • Demonstrate an advanced understanding of supported main system flows and possess a comprehensive understanding of how the system and others collectively integrate to contribute towards achieving business objectives
  • Participate in design discussions as a Development Lead and as such will play the part of a key decision maker in driving design decisions
  • Fulltime
Read More
Arrow Right

Sr Data Engineer

(Locals or Nearby resources only). You will work with technologies that include ...
Location
Location
United States , Glendale
Salary
Salary:
Not provided
enormousenterprise.com Logo
Enormous Enterprise
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 7+ years of data engineering experience developing large data pipelines
  • Proficiency in at least one major programming language (e.g. Python, Java, Scala)
  • Hands-on production environment experience with distributed processing systems such as Spark
  • Hands-on production experience with data pipeline orchestration systems such as Airflow for creating and maintaining data pipelines
  • Experience with at least one major Massively Parallel Processing (MPP) or cloud database technology (Snowflake, Databricks, Big Query)
  • Experience in developing APIs with GraphQL
  • Advance understanding of OLTP vs OLAP environments
  • Candidates must work W2, no Corp 2 Corp
  • US Citizen, Green Card Holder, H4-EAD, TN-Visa
  • Airflow
Job Responsibility
Job Responsibility
  • Contribute to maintaining, updating, and expanding existing Core Data platform data pipelines
  • Build and maintain APIs to expose data to downstream applications
  • Develop real-time streaming data pipelines
  • Collaborate with product managers, architects, and other engineers to drive the success of the Core Data platform
  • Contribute to developing and documenting both internal and external standards and best practices for pipeline configurations, naming conventions, and more
  • Ensure high operational efficiency and quality of the Core Data platform datasets to ensure our solutions meet SLAs and project reliability and accuracy to all our stakeholders (Engineering, Data Science, Operations, and Analytics teams)
What we offer
What we offer
  • 3 levels of medical insurance for you and your family
  • Dental insurance for you and your family
  • 401k
  • Overtime
  • Sick leave policy: accrue 1 hour for every 30 hours worked up to 48 hours
Read More
Arrow Right

Sr. Data Engineer

We are looking for a Sr. Data Engineer to join our team.
Location
Location
Salary
Salary:
Not provided
bostondatapro.com Logo
Boston Data Pro
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Data Engineering: 8 years (Preferred)
  • Data Programming languages: 5 years (Preferred)
  • Data Developers: 5 years (Preferred)
Job Responsibility
Job Responsibility
  • Designs and implements standardized data management procedures around data staging, data ingestion, data preparation, data provisioning, and data destruction
  • Ensures quality of technical solutions as data moves across multiple zones and environments
  • Provides insight into the changing data environment, data processing, data storage and utilization requirements for the company, and offer suggestions for solutions
  • Ensures managed analytic assets to support the company’s strategic goals by creating and verifying data acquisition requirements and strategy
  • Develops, constructs, tests, and maintains architectures
  • Aligns architecture with business requirements and use programming language and tools
  • Identifies ways to improve data reliability, efficiency, and quality
  • Conducts research for industry and business questions
  • Deploys sophisticated analytics programs, machine learning, and statistical methods to efficiently implement solutions
  • Prepares data for predictive and prescriptive modeling and find hidden patterns using data
Read More
Arrow Right

Sr. Data Engineer

We are looking for a Sr. Data Engineer to join our team.
Location
Location
Salary
Salary:
Not provided
bostondatapro.com Logo
Boston Data Pro
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Data Engineering: 8 years (Preferred)
  • Data Programming languages: 5 years (Preferred)
  • Data Developers: 5 years (Preferred)
Job Responsibility
Job Responsibility
  • Designs and implements standardized data management procedures around data staging, data ingestion, data preparation, data provisioning, and data destruction
  • Ensures quality of technical solutions as data moves across multiple zones and environments
  • Provides insight into the changing data environment, data processing, data storage and utilization requirements for the company, and offer suggestions for solutions
  • Ensures managed analytic assets to support the company’s strategic goals by creating and verifying data acquisition requirements and strategy
  • Develops, constructs, tests, and maintains architectures
  • Aligns architecture with business requirements and use programming language and tools
  • Identifies ways to improve data reliability, efficiency, and quality
  • Conducts research for industry and business questions
  • Deploys sophisticated analytics programs, machine learning, and statistical methods to efficiently implement solutions
  • Prepares data for predictive and prescriptive modeling and find hidden patterns using data
Read More
Arrow Right

Sr. Civil Engineer

Contribute your expertise, skills, and experience as a Civil Engineer by joining...
Location
Location
United States , Chicago
Salary
Salary:
Not provided
kdmengineering.com Logo
KDM Engineering
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BS in Civil Engineering or other accredited Engineering degree
  • EIT or PE license with ability for reciprocity in other states preferred
  • 7+ years of experience
  • Experience or knowledge of: Surveying
  • Construction and design feasibility
  • Utilities infrastructure
  • Land development, transportation, and water/drainage
  • Power distribution
  • Experience and proficiency in AutoCad Civil3D
  • Understanding of and experience in applying regulatory agency laws, ordinances and regulations for municipality, county, state, and federal agencies permitting submittals
Job Responsibility
Job Responsibility
  • Contribute to a project team consisting of professional engineers and designers involved in the design, modification, and analysis of all facets of civil engineering
  • Work on challenging assignments that include investigating, troubleshooting, and solving a wide variety of civil engineering-related issues
  • Create civil designs from preliminary to as-built stages
  • Produce civil engineering plans, surveys, data and information, construction documents, and related reports in a clear and concise manner to meet client specifications
  • Act as a team lead in coordinating detailed design phases for all aspects of civil engineering work
  • Prepare, review, and/or approve proposals, contracts, or cost estimates
  • Negotiate revisions, changes, and additions to contractual agreements with sub-consultants and clients
  • Perform and/or oversee designs for underground and overhead powers installations
  • Lead efforts to ensure projects are completed satisfactorily, on time, and within budget
  • Coordinate design activities to ensure installation and operations will comply with specifications, codes, and client requirements
What we offer
What we offer
  • Positive team environment
  • Competitive salaries
  • Hybrid work schedule
  • Growth opportunities
  • Training and professional development
  • Health, dental, and vision insurance
  • 401(k)
  • Life, long-term disability, and short-term disability insurances
  • Paid time-off
  • Paid holidays
  • Fulltime
Read More
Arrow Right