HiArc · 16 hours ago
Senior Quality Engineer-Medical Device
Merrimack, NH
Full-time
Onsite
Senior Level
5+ years expHiArc is a company dedicated to creating tailored medical technologies for its clients. The Senior Quality Engineer will be responsible for implementing quality assurance standards and procedures, conducting audits, and collaborating with cross-functional teams to ensure product quality and compliance with regulations.
Health CareInformation TechnologyManufacturingMedical
Hiring Manager
Shelley Woodcock
Responsibilities
Plan, devise and implement Quality Assurance standards, instructions, and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment for an assigned complex project or area to assure the highest quality levels and cost‑effective compliance with contractual and HIARC requirements
Develop test techniques and procedures as required
Assist in planning, devising and implementing Quality Assurance standards, instructions, and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment for an assigned project or area to ensure the highest quality levels and cost‑effective compliance with contractual and Company requirements
Apply basic engineering and scientific principles and techniques to assist in the development and establishment of quality assurance programs which provide and maintain the highest quality levels for an assigned project, product, or area
Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of assigned products or production equipment
Conduct experiments and audits to evaluate operating characteristics of products or processes
Evaluate data from experiments and prepare reports and summaries outlining results and recommend revisions or modifications to the product or process to maintain or improve product quality
Support customer and regulatory audits and assist in completing corrective actions to resolve any findings from audits
Assist in evaluating producibility and reliability of the finished product, ensuring that all established standards and regulations are met
Assist in determining equipment to be used to maximize manufacturing effectiveness and minimize cost
Assist in complete failure analysis investigations to determine the root cause and take appropriate corrective action to revise design, methods and inspection/test instructions to prevent failure recurrence
Evaluate and monitor the quality of vendor services and goods and recommend selection of optimum vendors
Serve as a member of Material Review and Configuration Control Boards
Support the manufacturing process in resolving design problems, assist in the transition of products from development into production
Review and assess Engineering Change Orders (ECOs) for design and process changes to ensure compliance with quality and regulatory requirements
Collaborate with cross-functional teams to provide quality input for verification and validation activities
Lead investigations, root cause analysis, and corrective action implementation to ensure timely closure of customer complaints
Manage RMA process from product return through evaluation and disposition, driving trend analysis, and systemic issue resolution
Prepare and present quality performance metrics and dashboards to support program reviews and leadership decisions
Support MES configuration and data integrity to ensure accurate quality record capture and compliance
Monitor use of test equipment to ensure efficient utilization
Recommend corrective action related to design, application, or procedures
Evaluate test specifications and test equipment for purposes of improving current methods and operations
Perform initial tests with equipment and instruct test personnel in its use
Provide instruction to others in the fabrication and operation of test equipment, and in the interpretation of test procedures
Perform special studies and assignments as designated
Qualification
Required
A Bachelor's degree in a technical discipline and 5 years of related experience to be proficient in the above areas; or an equivalent combination of education and experience
Prior experience in Medical Device or Pharmaceutical manufacturing support
Preferred
FDA and ISO audit experience (13485, 21 CFR 820, 803, 806 and 14971)
ISO 13485:2016 Lead auditor certification
Green Belt/Black Belt proficiency desired or CQE
Hands-on experience working with MES for production traceability
Proficiency in PLM systems for managing change control and documentation
Proficiency in data analytics tools such as Minitab, Tableau, PowerBI etc
Benefits
Most locations offer a 9/80 schedule, providing every other Friday off
Competitive compensation & 401(k) program to plan for your future
Robust medical, dental, vision, & disability coverage with qualified wellness discounts
Basic Life Insurance and Additional Life & AD&D Insurances are available
Flexible Vacation & PTO
Paid Parental Leave
Generous Employee Referral Program
Voluntary Benefits Available: Longer Term Care, Legal, Identify Theft, Pet Insurance, and more
Voluntary Tricare Supplement available for military retirees
Company
HiArc
At HiArc we believe clients don’t need another vendor, they need a strategic partner who gets it.
201-500 employees
H1B Sponsorship
HiArc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (1)
Funding
Current Stage
Growth StageRecent News
NH Business Review
2025-08-09
2022-03-10
Company data provided by crunchbase