Quality Specialist Iii $70K Annually Must Have Iso 13485 Experience

POSITION OVERVIEW: The Quality Specialist III will be expected to use training, experience, and good judgement to perform tasks assigned in the Quality Department.

JOB RESPONSIBILITIES:

• Leads the CAPA program at BioTouch (Global) including leading CAPA Review Board, and CAPA & Continuous Improvement Projects
• Leads the Complaint program at BioTouch including tracking, trending, and updating associated metrics
• Completes Regulatory Risk Assessments related to Complaints
• Leads the Supplier Management program
• Assists with updating Quality Metrics as assigned
• Completes internal audits per the internal audit schedule and as assigned
• Conducts process walks of procedures with other departments
• Provide back-up coverage for other quality positions as needed.
• Other duties as assigned.

ABILITIES REQUIRED:

• Basic knowledge of Microsoft Windows & Office
• Thorough knowledge and minimum 3 years experience working in a regulated environment such as medical devices and experience with Quality Management Systems and Medical Device Regulations: CFR 820, ISO 13485
• Ability to prioritize and shift priorities quickly as needed
• Proficient verbal and written communication skills
• Team-oriented with commitment to the success of the team and organizational goals to track and complete assignments
• Ability to multi-task

QUALIFICATIONS

• College degree (Associate, Bachelor, or equivalent experience) in sciences, quality management, biology, or similar.
• Must possess ability to sit and/or stand for long periods of time.

DISCLAIMER

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Job Type: Full-time

Pay: $60,000.00 - $70,000.00 per year

Benefits:

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

Experience level:

• 1 year
• 5 years

Schedule:

• Monday to Friday

Work setting:

• In-person
• Manufacturing facility

Work Location: In person