Performs sampling, inspection, testing, and sampling of incoming materials; conducts required in-process and final inspection of reprocessed devices their packaging; performs pre- and post-sterilization inspection of batches and review of Batch Production Records (BHRs). Strictly follows and enforces established procedures and policies needed to meet the demands of Quality in a regulated medical device company.
Essential Duties and Responsibilities
- Perform inspections of purchased components, reprocessed devices and their packaging, sterilization records, and Batch History Records (BHRs) to controlled procedures and pre-determined acceptance criteria.
- Accurately document the results of the inspections and testing.
- Participate in the creation and/or revision of procedures for the inspection function.
- Ensures appropriate labeling, storage and handling of product and materials throughout the manufacturing facility to prevent mix-ups.
- Ensures Quarantine areas are orderly maintained and scrapping requests made by the Materials Review Board (MRB) are fulfilled.
- Responsible for updating material status in ERP system following the completion of Quality activities.
- Ensures line clearance and material reconciliation activities are conducted as dictated by company procedures.
- Assist with nonconforming product investigations, CAPAs, and customer complaints.
- All other reasonable duties, as assigned.
Education, Qualifications and Skills
- High School Diploma or equivalent; 1-2 years of Quality Inspection experience is preferred.
- Must have good English written and verbal communication skills; Good arithmetic skills are required
- Mechanical aptitude and working knowledge of measure instruments is desired
- Experience with 21CFR820, Quality Systems Regulation and ISO 13495 a plus.
- Must demonstrate a high level of attention to detail in completion of tasks and cross-referencing of information in several locations.
- Must demonstrate the ability to multi-task and prioritize in a fast-paced environment, and possess flexibility when juggling numerous projects simultaneously.
- General proficiency in Microsoft Word and other applications (Excel, PowerPoint, Adobe Acrobat, and Visio).
- Experience with J.D. Edwards ERP software use a plus.
- Must grasp instructions and information rapidly and apply them with little supervision self-motivated, self-starter.
- Strong verbal, written, organizational, time management and interpersonal skills.
- This job operates in a clerical, office, as well as a manufacturing setting. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
- While performing the duties of this job, the employee is frequently exposed to odors, fumes, dust or airborne particles, moving mechanical parts and vibration. The noise level in the work environment and job sites can be loud.
- 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 regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.
- The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.