This position performs quality inspection and quality acceptance of incoming components, in-progress product assembly and final product inspection. This position is ultimately responsible for ensuring the manufacturing quality of our product. The ideal candidates will have a strong mechanical acumen, with sound logical reasoning and analytical skills.
Comply with applicable FDA regulations and ISO 13485 requirements.
Adhere to company Quality Management System (QMS).
Responsible for performing and documenting incoming, in-progress and final product acceptance testing.
Creates inspection documents and maintains the incoming inspection room.
Verify that documents required of suppliers, such as certificates of conformance and first article inspection results are provided for incoming goods, which include materials, parts, assemblies, machines, accessories, electronic devices, PCBs, and fabricated metal parts.
Use standard measuring instruments, gages and controlled components to verify functional fit and dimensional checks. Test incoming goods, such as electronic devices and PCBs.
Develop and maintain incoming inspection files and records.
Document in-house inspection results.
Responsible for updating and maintenance of manufacturing product files upon final inspection and acceptance of products.
Logs defects in QA defect management reporting system. Assists in analysis as deemed necessary.
Maintain records for inspection data and unplanned events.
Creates detailed Quality Reports as required. Responsible for initiating non-conformance reports and working with Engineering and Manufacturing for the resolution of problems. Additionally, responsible for reviewing the disposition of parts, sub-assemblies and product as well as releasing finished goods into inventory.
Participates in the Material Review Board meetings; initiate actions and facilitate through closure.
Take part in root cause analysis and support corrective and preventive actions.
Work with Supply Chain in returning nonconforming goods to suppliers.
Maintain calibration program, including reviews and approvals of calibration reports.
Analyze problems and recommend changes. Support FDA inspections, external and internal ISO audits.
Maintain a safe and healthful work environment.
Performs related duties as assigned
Superior interpersonal skills.
Articulate verbal and written communication.
Well-developed organizational and planning skills.
Collaboration and consensus building in a team environment.
Self-motivated—works independently with little supervision.
Analytical and resourceful problem solving.
Isolation of key issues from complex information.
Identification of patterns and trends in unplanned events and non-conformances.
Meticulous documentation and recordkeeping habits.
Calibration system maintenance.
Intermediate Computer skills: Microsoft Office Suite (including PowerPoint, Office, Outlook, Visio, Word, Excel)
Functional understanding of the ISO 13485 International Standard.
Practical knowledge of the FDA Code of Federal Regulations (CFR), Title 21, Part 820.
QMS requirements, including nonconformance reporting (NCR), corrective and preventive action (CAPA), Material Review Board (MRB), and Root Cause Analysis (RCA).
Incoming, in-process, and outgoing inspection techniques.
Use of gages and standard measuring instruments.
Familiar with current good manufacturing practices (cGMP).
Understanding of common manufacturing processes.
Knowledge of first article inspection (FAI) and certificates of conformance (CofC).
Support of FDA inspections; external and internal ISO audits.
Education and Experience:
High School degree or equivalent. Associate degree preferred.
3–5 years in a quality assurance role in a regulated industry—medical device manufacturing preferred.
If you are smart, hardworking, have great ideas, and want to play a crucial role in the modern-era pharmaceutical industry, then join our team! ARxIUM offers a competitive salary and benefits package including a company match 401K and opportunity for personal and professional growth. In addition, you will be eligible to participate in the ARxIUM Employee Profit Sharing Bonus Plan, intended to give employees the opportunity to increase their earnings by contributing to the profitability of ARxIUM.
Please note that candidates need to be eligible to work in the U.S. now and in the future without ARxIUM sponsorship for an employment-based visa.
ARxIUM is an Equal Opportunity Employer – Disability and veteran. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status or other characteristics protected by law.
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DISCLAIMER The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
ARxIUM is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status or other characteristics protected by law.