Senior Quality Assurance Specialist
At Pajunk Medical Systems, we believe that success derives from both, high-quality and innovative products, and excellent customer service. As a Senior Quality Assurance Specialist, responsibilities include monitoring, inspecting, and proposing measures to verify or improve the company's final products and processes in order to meet established quality standards. This position requires excellent organizational skills and attention to detail as it relates to critical aspects of the Quality System.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Directs quality initiatives by requiring adherence to quality assurance policies and procedures; develops quality standards, processes and new models; drives and implements quality improvement changes.
- Assist Production department with process validation and equipment/facility qualifications.
- Participate in internal audit program, including sharing of findings and determination of proper corrective and preventive actions.
- Maintain complaint management processes; review, investigate, and respond to complaints made by customers or third parties.
- Perform root cause analysis and implement corrective action for quality-related findings.
- Manage the annual audit schedule for critical suppliers in accordance with internal procedures.
- Assist with new supplier approvals as part of the supplier approval program.
- Perform supplier audits (remote or on-site); implement and monitor any resulting nonconformance and supplier corrective actions (SCAR).
- Develop, communicate and implement quality agreements with new and existing suppliers.
- Review nonconforming product and recommend disposition.
- Maintain, control, and distribute controlled documents and records related to the Quality Management System.
- Perform and document monthly and quarterly monitoring of cleanroom and warehouse.
- Document and maintain records of all quality activities as required by the Quality Management System.
- Prepare reports, analyze data and assist Quality Management in development of action plans to achieve departmental benchmarks.
- Maintain departmental Key Performance Indicators (KPI) in order to assess statistical trends.
- Provide ongoing support of the day-to-day activities of the Quality Assurance team, and work with Quality Management to ensure daily goals and metrics are met.
- Perform other related duties as assigned.
QUALIFICATIONS/SKILLS:
- Bachelor's degree from four-year college or university; or equivalent combination of education and experience.
- 3-5 years of current experience in medical device and/or pharmaceutical industry
- Prior experience working in an FDA regulated environment preferred
- Good written and verbal communication skills
- Excellent root-cause analysis, problem-solving and analytical skills
- Keen organizational skills and attention to detail
- Teamwork and collaboration
- Ability to use measuring devices like gauges, meters, calipers and computers
- Ability to understand product drawings, specifications and visual work instructions.
- Documentation and reporting skills
- Communicate effectively with technical staff, production teams, and leaders
- Comfortable standing or walking for long periods of time
- Ability to stand, sit, stoop, kneel, crouch, stretch, and reach with hands
- Must be able to lift and move up to 50 lbs.
- Basic computer skills (MS Word, MS Excel, MS Outlook)
- Must be able to read, speak and write effectively in English
- A current US work authorization is required
This position is located in Alpharetta, GA.
This position reports to the Quality Assurance and Regulatory Manager.
This position has no direct reports.