126 applicants
Merrimack Manufacturing · 2 days ago
Quality Engineer
Manchester, NH
Full-time
Onsite
Mid Level
3+ years exp
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Responsibilities
Work cooperatively with team members and in compliance with standards and regulations to transition products from development to manufacturing.
Provide guidance in the development of new production processes within medical devices.
Drive the development, implementation, and approval of PFMEAs and control plans.
Develop inspection processes and sampling plans based on risk levels.
Ensure compliance with standards and regulations, and resolve nonconformance issues.
Facilitate the development, implementation, and approval of Device Master Records and Device History Records.
Review procedures for continuous improvement and workflow enhancement.
Lead investigations for root cause and corrective actions using data analysis and problem-solving skills.
Make risk-based decisions using critical thinking and deductive reasoning.
Develop and approve technical documents, such as Master Validation Plans and Quality Plans.
Collect and evaluate data for system and process improvements.
Provide reliability and statistical analysis for Quality-related activities.
Participate in audits and regulatory inspections.
Utilize Microsoft Office software for work purposes.
Qualification
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Required
Bachelor’s degree or equivalent experience in Industrial, Mechanical or related engineering / life sciences related discipline.
3 + years of experience in occupation related to Quality Control of medical devices.
Experience with compliance, with applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016 is required.
Experience participating in internal and external audits.
Company
Merrimack Manufacturing
Merrimack Manufacturing is an industrial machinery manufacturing company that provides technical solutions for construction equipment.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase
