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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in quality engineering systems and practices, with a strong focus on statistical methodologies, risk management, and process validation in a regulated manufacturing environment. Proficient in developing testing plans and collaborating with cross-functional teams to ensure product quality and compliance.
Highest-signal resume keywords
Quality Engineering SystemsStatistical MethodologiesRisk Management (ISO14971)Advanced Product Quality Planning (APQP)ISO13485 Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Statistical Analysis SoftwareTooling Development and QualificationProcess Control PlansVerification and Validation ProtocolsMetrology Lab ExperienceISO Standards KnowledgeProject ManagementTechnical WritingAnalytical SkillsAttention to Detail
Soft Skills
Effective CommunicationPresentation SkillsFacilitation Skills
Tools & Technologies
MS Office SuiteMS ProjectVisioCAD Software (SolidWorks, Autodesk)
Industry Keywords
ISO Regulated ManufacturingMedical Device ManufacturingMaterial Review Boards (MRB)FMEASPC & CPk Analysis
About the role
Key responsibilities & impact- Utilize and maintain quality engineering systems and practices in collaboration with Agiliti manufacturing and design centers
- Support quality decisions and practices as a team member
- Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues
- Apply statistical methodologies to assess and resolve potential product and quality system issues
- Develop and maintain testing plans, models, and methods for raw materials, materials in process, and finished goods
- Collaborate with Design, Manufacturing, and Supply Chain teams to select and monitor suppliers
- Plan, execute, and maintain equipment validation activities (IQ, OP, and PQ)
- Plan, execute, and maintain tooling verification and validations with manufacturing and engineering teams
- Participate in plant Material Review Boards (MRB) to investigate and disposition product nonconformances
- Develop and maintain process control plans for laser cutting equipment and robotic welders
- Collaborate with manufacturing to develop in-process inspection plans
- Support medical device manufacturing activities, including Risk Management, Process FMEA, and Quality Control Plans
- Plan, develop, and execute verification and validation protocols with oversight
- Lead advanced product quality planning activities and assist in preparing new product designs for certification testing
- Participate in projects and cross-functional teams and may lead small-scale projects
Requirements
What you’ll need- Bachelor’s Degree (BS) in Engineering, Scientific, or Technical related subject required
- 0-5 yrs. of relevant experience, preferably in an ISO regulated manufacturing environment
- ISO13485 experience preferred, but not required
- Working knowledge and experience in metrology lab preferred, but not required
- Working knowledge of ISO14971 Risk Management preferred, but not required
- Working knowledge of IEC 60601-1 Safety standards preferred, but not required
- Advanced Product Quality Planning experience (APQP) preferred, but not required
- Use of statistical analysis software for SPC & CPk Analysis
- Tooling and fixturing development and qualification (FAI and Gage R&R)
- Proficient computer skills in MS Office Suite, including MS Project and Visio
- Working knowledge of CAD software preferred (i.e., SolidWorks, Autodesk, etc.)
- Strong analytical skills and attention to detail
- Strong technical writing skills and effective communication skills
- Strong presentation, facilitation, and project management skills
- May be required to obtain certain vaccinations or provide proof of current vaccination status based on customer and/or company requirements
Benefits
Comp & perks- Health insurance options for Medical, Dental & Vision plans
- Short- and Long-Term Disability plans
- Flexible Spending Accounts
- Health Savings Accounts
- Life Insurance Options
- Paid Time Off
- 401K Saving Plan with employer match
- Employee Discounts
- Tuition Reimbursement
- Daily Pay program
- Employee Assistance Program
- Wellness programs
- Required vaccinations covered at a participating clinic, if applicable
- Reasonable accommodations for qualified individuals with disabilities