Quality Specialist (P1 East) - Hoover, AL

The Quality Specialist ensures the company's compliance with quality system regulations and standards, focusing on product inspection, quality documentation, and system integrity. Key responsibilities include performing device component and finished device inspections, reviewing device history records, supporting nonconforming materials, and maintaining calibration systems. The role requires proficiency in blueprint reading, precision measuring instruments, and knowledge of ISO13485 and 21 CFR Part 820, Part 11, with a minimum of 3 years experience in medical device manufacturing.

Must Have

• Perform tasks associated with the implementation and maintenance of the company’s Quality Management System
• Inspect device components and finished devices per established inspection procedures
• Review and maintain completed device history records
• Support the nonconforming materials system, including material review board (MRB) efforts
• Support production activities and the transfer of product out of Quality, ensuring that necessary documentation is generated and maintained
• Perform and maintain instrument and gage calibrations to ensure all daily production requirements are met
• Maintain organized recordkeeping of the overall calibration system
• Assist with validation activities to support manufacturing needs as required
• Support training activities as required
• Proficient in blueprint reading (GD&T)
• Proficient skill with precision measuring instruments (e.g. micrometers, calipers, gauges, optical comparators, etc.)
• Basic knowledge of ISO13485 and 21 CFR Part 820, Part 11
• Computer literacy with standard software applications
• High School Graduate required
• Minimum of 3+ years in a medical device manufacturing environment

Good to Have

• Bachelor’s Degree preferred
• Experience in a regulated medical device or international quality standard-based system preferred

careers

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The Quality Specialist can heavily influence the company’s compliance with quality system regulations and standards for product inspection, quality documentation controls, and quality system integrity. The success of the company overall based on their ability to coordinate internal and receiving inspections. The company’s compliance with Quality System Regulations and standards governing document changes and historical records. The perception of suppliers and regulators about the competence levels of P1 in meeting requests for information and in complying with applicable regulations.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Perform tasks associated with the implementation and maintenance of the company’s Quality Management System
• Inspect device components and finished devices per established inspection procedures
• Review and maintain completed device history records
• Support the nonconforming materials system, including material review board (MRB) efforts
• Support production activities and the transfer of product out of Quality, ensuring that necessary documentation is generated and maintained
• Perform and maintain instrument and gage calibrations to ensure all daily production requirements are met
• Maintain organized recordkeeping of the overall calibration system
• Assist with validation activities to support manufacturing needs as required
• Support training activities as required
• Minimal travel (<10%) required for training, audits, etc.

QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Proficient in blueprint reading (GD&T)
• Proficient skill with precision measuring instruments (e.g. micrometers, calipers, gauges, optical comparators, etc.)
• Basic knowledge of ISO13485 and 21 CFR Part 820, Part 11
• Must be flexible and able to adapt to change
• Strong written and verbal communication skills
• Must be able to exercise independent judgment and discretion
• Highly detail-oriented
• Communicates and works well with employees of all positions
• Computer literacy with standard software applications
• Ability to prioritize work and to perform multiple tasks simultaneously while adhering to deadlines
• Good problem-solving and analytical skills
• Ability to understand and follow directions, complex policies, and procedures
• Experience in a regulated medical device or international quality standard-based system preferred

EDUCATION AND/OR EXPERIENCE

• High School Graduate required
• Bachelor’s Degree preferred
• Minimum of 3+ years in a medical device manufacturing environment

Please note that any offer of employment made by the company is contingent upon the successful completion of a pre-employment background investigation to include a pre-employment drug screen.

The company is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.