Date posted: March 14, 2025
Pay: $65,000.00 - $85,000.00 per year
Job description
Quality Specialist – Medical Devices, Electronics
The ideal candidate will have a thorough understanding of Quality Management Systems (QMS) applicable to medical devices as well as electronics manufacturing processes and equipment.
In this position, you will take ownership of, organize, and direct all aspects of our Quality Assurance Program. Serve as the primary point of contact for all QSR regulatory concerns, non-conformance issues, and documentation requests related to QSR compliance. You will support all aspects of electronic and mechanical assembly, including Surface Mount Technology (SMT), through-hole assembly, convection reflow, wave solder, conformal coating, final assembly and test.
This is NOT a remote position - candidates need to be able to report onsite in order to be considered for the role. Work schedule is Monday through Friday, 7:00 am to 3:30 pm.
Job Responsibilities:
- This role will be responsible for all root cause/corrective actions and leading floor initiatives to increase efficiency.
- Develop, document, and improve manufacturing processes
- Collect, trend and analyze internal performance metrics
- Assist leadership and team members with operational data measurement, analysis, and actions
- Train staff in staff in QMS, applicable QS requirements, quality concepts, tools, and processes as it relates to their job responsibilities.
- Assist in the development of procedures, work instructions and other documents
- Initiate and facilitate CAPA meetings (corrective / preventive actions) to drive root cause and permanent corrective actions
- Assist with internal and external audits
- Work with engineering to implement, support, and maintain the DHF and design change procedures
- Implement, support, and maintain the DMR and DHR
- Responsible for process documentation and ensuring it is kept current like Work Instructions, Standard Work documents, PFMEA, and Control Plans
- Provide design for manufacturability (DFM) input during design and development efforts
- Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality
- Leads and implements various product and process improvement methodologies
- Review the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
- Review processes for new and existing products and coordinate process validations
- Recommends process monitoring devices where applicable
- Develops various inspection techniques and procedures to ensure product integrity to design specifications
- Responsible for implementation of Incoming, In-Process and Final Inspection procedures
- Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence
- Acts as a lead in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis
- Works with suppliers, management, Engineers and Manufacturing associates as needed in the resolution of quality problems
- Performs other functions as required
- Position reports directly to Operations Manager
Qualifications
- Knowledge in QMS applicable to Medical Device manufacturing
- Ability to identify problems and initiate corrective and preventive actions
- Process productivity (efficiency and utilization) improvement skills
- Ability to solve practical and abstract problems and deal with a variety of variables in situations where only limited standardization exists
- Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of data with attention to detail and accuracy
- Ability to establish priorities and manage time effectively
- Possess excellent verbal and written communication skills and can present information effectively
- Professional, self-motivated, and focused on continual improvement
- Ability to work independently and/or on a team with minimal supervision
- Ability to manage multiple tasks simultaneously
- Proficient in Microsoft Word, Excel and Power Point
- At least 2 years’ experience in a Quality Assurance related role
- Medical Device/FDA experience desired
- At least three years in Electronics Manufacturing role
- Bachelor’s degree in engineering desired
Benefits:
- 401(k)
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Retirement plan
- Tuition reimbursement
- Vision insurance
Experience level:
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
- No nights
- No weekends
Work setting:
- In-person
- Manufacturing facility
Application Question(s):
- Are you able/willing to work onsite 100% of the time (this is not a remote position)?
Work Location: In person
Job Type: Full-time
Pay: $65,000.00 - $85,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
