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A bio tech company is seeking quality inspectors to join the team. Apply today if qualified and interview within 2-3 business days!
- This individual oversees/supports/performs routine and special assignments as requested for visual, dimension and functional inspections, line clearance and first articles per inspection instructions while maintaining efficiency of manufacturing operations. Documents and reports inspection findings/results and monitors corrective actions to inspection findings. Perform product identification and trace ability activities, as required.
- Monitors departmental documentation and activities, quality records and transactions in the operating system. Reviews, approves and maintains Device History Records for all manufacturing functions in accordance with applicable standards and regulations.
- Ensures quality standards/regulations are upheld and applies regulatory and QSRs/ISO knowledge to daily activities. Monitors quality requirements in accordance with the company quality Assurance policies and customer specifications. Ensure calibration and maintenance is performed in inspection equipment.
- Actively leads the shift in achieving departmental and company objectives. Leads shift/team activities in improvement efforts, both specific and of a more global nature. Acts as intermediary with management to communicate suggestions for improvements and provide feedback on team performance.
- Individuals may also be trained as back-up personnel to support QC Receiving/Inspection as needed. Must be able to read and interpret specifications and part drawing. Perform first article inspections to support component Qualification Test Plans (QTP's).
- Closes NCMR and work orders in LN per standard procedures.
- Basic math skills to determine appropriate sample sizes for inspection based on lot sizes
- Ability to assess product and process integrity/efficacy to defined standards and take appropriate action.
- Problem solving developed to the point of identifying process and standards in need of improvement and suggesting/initiating appropriate action.
- Performs daily activities with minimum supervision and demonstrates consistent ability to problem solve/resolve issues associated with various aspects/departmental functions with minimal assistance.
- Operates predominately independently for decision-making and coordinates with management.
- Demonstrated ability to schedule and prioritize departmental workload.
- Must be able to apply problem solving/decision making skill to personnel interactions and incidents to successfully diffuse potential problems.
- Can make quick, appropriate and effective decisions while consciously ensuring a quality culture, morale and departmental integrity are not negatively impacted.
- Established leadership skills.
- High School diploma or equivalent.
- 4-6 years' Inspection/ Quality Control experience in a medical device, high-volume manufacturing environment strongly desired.
- Broad understanding of standards, procedures, work instructions and drawings
- Solid understanding and demonstrated application of medical device regulations (QSRs, ISO, GMPs)
- Strong leadership and team building skills
- Proficient in word processing, familiar with Microsoft Office and spreadsheet manipulation
- Strong written and verbal communication skills demonstrated at cross-functional and various levels
- Able to perform as key trainer
- Process improvement skills and root cause analysis knowledge
- Ability to perform internal audits
- Full understanding of NCMR and MRB systems and ability to act as delegate for attendance
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.