Quality Assurance Specialist

POSITION SUMMARY:

The desired candidate will have experience working as a hands-on Quality Inspector. This individual will work in a multi-faced role whereby providing expertise and support to the various roles within the Quality department. Specific experience and responsibilities will include but are not limited to: Conducting final lot release, performing incoming and final inspections; releasing materials; Generating Certificate of compliance and equipment monitoring.

ESSENTIAL FUNCTIONS / MAJOR RESPONSIBILITIES:

• Conduct final lot release to ensure final QA Documentation (i.e., COCs, shipping labels, lot numbers, product quantity, sales numbers) verification prior to shipping of product.
• Generate Customer Certificate of Compliance
• Review inspection documentation ensuring requirements are met.
• Complete NCMR's as required
• Perform mechanical and functional inspections (i.e., micrometers, verniers, RAM Optical, and sterile packing testing) on manufactured parts to ensure drawing requirements are met.
• Ensure completion and accuracy of inspection records.
• Practice GMP; accurate documentation; and reporting to ensure compliance with ISO-13485 and FDA CFR 820 requirements
• Assist with Spectras calibration program and equipment monitoring as required.
• Responsible for ensuring compliance with all applicable procedures and regulations.
• Create/update custom labels for packaging.
• Participate in quality projects, as requested

DESIRED SKILLSET:

• High School Diploma
• 1-3 yrs in a similar quality inspection role
• Prior medical device experience, preferred.
• Working knowledge of FDA Quality System requirements, ISO 13485 a plus
• Excellent organizational, verbal, written communication, and problem-solving skills
• Possess above-average interpersonal skills demonstrating the ability to work with others in a professional, positive and collaborative manner
• Ability to work in a fast-paced environment and to meet tight deadlines
• Willingness to learn, possess a can-do attitude, and motivated to succeed and grow
• Ability to multi-task with strong attention to detail
• Experience working with MRP/ERP systems required
• Proficient in MS Office Suite, and of Statistical Process Control Practices
• Experience working in a start-up environment, helpful

• Self-driven and highly organized with the ability to work independently and cooperatively in a team setting

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, grip, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk and hear. The employee must occasionally lift and /or move up to 45 pounds, depth perception and ability to adjust focus.

ADA Statement: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

At-Will Employment: I acknowledge that my employment with the Company is on an at will basis which means that either I or the Company can end the employment relationship at any time, for any reason, with or without prior notice.

An Equal Opportunity Employer: Spectra believes that all persons are entitled to equal employment opportunity. The Company will not discriminate or tolerate discrimination against any employee or applicant because of race, color, creed, religion, genetic information, sex, sexual orientation, national origin, age, status with regard to public assistance, marital or veteran status, disability or any other characteristic protected by local, state or federal law. Equal employment opportunity will be extended to all persons in all aspects of the employer-employee relationship, including recruitment, hiring, training, promotion, transfer, discipline, layoff, recall and termination. Disabled applicants may request any reasonable accommodation needed to enable them to complete the application process.