JOB DESCRIPTION

Quality Specialist – Administrative Quality Document Control Management
The ideal candidate will have a thorough understanding of Quality Management Systems (QMS) applicable to medical devices.
In this position, you will take ownership of, organize, and direct all aspects of our Quality Management System. Serve as the primary point of contact for all QMS regulatory concerns, non-conformance issues, and documentation requests related to QMS compliance. Electronics manufacturing experience a plus.

Qualifications

• Thorough knowledge of how quality systems work as applicable to FDA/Medical Device manufacturing (strongly preferred) or other highly regulated industries.
• 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 in a team with minimal supervision
• Ability to manage multiple tasks simultaneously
• Proficient in Microsoft Word, Excel and Power Point
• Ability to identify problems and initiate corrective and preventive actions.
• Ability to solve practical and abstract problems and deal with a variety of variables in situations where only limited standardization exists
• At least 2 years’ experience in a Quality Management related role
• Electronics manufacturing experience desire

Experience level:

• 2 year

Job Responsibilities:
This role will be responsible for all aspects of the QMS including, but not limited, to the following:

· Keeping quality process documentation current and compliant this includes product samples, work instructions, forms, procedures, logs and other documents

• Assist in the development of new procedures, work instructions and other documents
• Perform regular internal audits of the QMS
• Train and maintain all training records for staff on applicable quality system requirements, quality documents, quality tools, and processes as it relates to their job responsibilities
• Document root cause/corrective actions.
• Assist leadership and team members with operational data measurement, analysis, and actions
• Collect, trend and analyze internal performance metrics.
• Review the adequacy and correctness of Assembly Procedures, Drawings, Component Specification, Process Control Plans, etc.
• Work with engineering to implement and maintain production design change procedures
• Implement, support, and maintain the DMR and DHR
• Support regulatory and agency inspections, audits, investigations, and inquiries
• Review processes for new and existing products and coordinate process validations.
• Team participation in various inspection techniques and procedures to ensure product integrity to design specifications
• Responsible for implementation of Incoming, In-Process and Final Inspection procedures and work instructions.
• Ensure the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence
• Performs other functions as required
• Assist Management Representative with Quality subject matters.
• Position reports directly to Operations Manager.

Qualifications

• Thorough knowledge of how quality systems work as applicable to FDA/Medical Device manufacturing (strongly preferred) or other highly regulated industries.
• 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 in a team with minimal supervision
• Ability to manage multiple tasks simultaneously
• Proficient in Microsoft Word, Excel and Power Point
• Ability to identify problems and initiate corrective and preventive actions.
• Ability to solve practical and abstract problems and deal with a variety of variables in situations where only limited standardization exists
• At least 2 years’ experience in a Quality Management related role
• Electronics manufacturing experience desired

Job Type: Full-time

Experience level:

• 2 years

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)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Job Type: Full-time
Pay: $65,000.00 - $85,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: In perso