Quality Analyst II

Job Summary:

Develops and implements processes and procedures meant to improve quality throughout the organization.

Essential Job Duties and Responsibilities:

• Works Independent with minimal technical guidance
• Relies on experience and judgement to plan and accomplish goals.
• Ability to coach, mentor and train others on all jobs within the department
• Work with Engineering, Production and Quality to complete the Batch process
• Responsible for last review of the DHR/Scanning and Filing physically
• Review and send customer QA data (review CoC/CofA) for shipment. Creating manual QA data/CoC as required
• Creation of Tracking Folders/Customer Data
• Responsible for assistance with DCN/ECO as required
• Responsible for redlining /relabeling activities through an ECO process
• May assist with NPD launch
• Responsible to attend to Pre-PQ meetings as required
• Responsible for Supporting ISO 13485 system requirements
• May be required to lead and maintain gaging calibration cycles working with the different departments. This includes generate GNR/ANR/PO/IRF and certifications
• May be required to maintain customer retains and every 6hrs retains
• Maintain Tailgate samples and delivery to warehouse for shipment
• Responsible for Setting Up/Creating/Updating SPC files/Control Limit
• Maintains MRB/PMRB area for compliance
• Assisting inspectors to ensure they have all tools necessary to perform their daily tasks
• May perform internal audits per ISO Internal Audit Schedule
• May compile and verify QA records for customers submission
• Support CAPA activities if needed
• Proper control of all records and retention periods
• May cover quality inspector as needed
• May be required to monitor pressure/temperature monitors
• Maintain gaging cabinets and ensure calibration is maintained
• Handle, transport and reconcile controlled substances throughout the shift as required
• Understand and complete drug specific documentation as needed
• Working with drug delivery in assembly
• Batch History Records/Customer approval work flow
• Support an investigation for any quality failures and improvements
  
  

Leadership Competencies:

• Action Oriented – Ability to take on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm.
• Collaborates – Builds partnerships and works collaboratively with others to meet shared objectives.
• Decision Quality – Makes good and timely decisions that keep the organization moving forward.
• Drives Results – Consistently achieves results, even under tough circumstances.
• Ensures Accountability – Holds self and others accountable to meet commitments.
• Instills Trust – Gains the confidence and trust of others through honesty, integrity and authenticity.
  
  

Essential Qualifications:

• High school diploma or equivalent experience.
• Minimum 6 years of Quality experience in the plastics industry, clean room/medical device assembly.
• Knowledge and practical understanding of various assembly Inspection methods and inspection equipment.
• Attention to detail and ability to manage multiple tasks and priorities.
• Excellent interpersonal and communication skills
• Proficient PC skills in a windows environment, Microsoft Word and Excel.
• Working knowledge of ISO, FDA, GMP, and OSHA standards preferred.
• Ability to read, write and communicate in English.
  
  

ADA Requirements:

• Stand, walk, bend, squat, twist, reach or otherwise move frequently
• Occasional repetitive motion and grasping
• Occasional climbing to reach areas on machines or racks
• Lift, move or otherwise transfer up to 50 lbs. occasionally, >20 lbs. frequently
• Typically sits, grasps items or performs keyboarding for occasional operation of a computer
• Exposure to typical machine shop physical hazards which may require respiratory protection
  
  

At SMC Ltd. we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process.

SMC Ltd. is an equal opportunity employer. M/F/D/V; this organization uses E-Verify.

Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.

All applicants must be authorized to work in the US.

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