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23 days old

2nd shift Sr. Quality Control (QC) Inspector, San Diego, CA

Kelly Services
San Diego, CA 92108
**2nd shift Sr. Quality Control (QC) Inspector, San Diego, CA**



**Schedule/Shift: 2nd shift, Mon.-Fri., 3:00pm-11:30pm**



**Summary of Position:**




+ 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 traceability 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.

+ Provides documented training within the shift/department including temporary/contract employees.

+ Initiates Non-Conforming Materials Reports (NCMRs) as required and performs trending of key inspection process metrics. Effectively organized personnel within the shift/dept. on system changes/daily tasks.

+ 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 (QTPs). Closes NCMR and work orders in LN per standard procedures.



**Essential Functions:**




+ Performs and Documents Hourly Inspections

+ Reviews Documents for Completeness, Approves and Files

+ Performs and Documents Line Clearance

+ Perform and Document Training, Ensures Integrity and Consistency on Shift, Interfaces with Management.

+ Lead Shift Improvement and Problem Resolution Efforts. Troubleshooting - Investigate and Resolves Daily Issues

+ Develops inspection plans in conjunction with Production area Quality Engineer. Supports QTP execution for new components.

+ Performs, Documents and Files First Articles and Retention Samples

+ Administrative

+ Meetings

+ Carries out duties in compliance with established business policies.



**Job Requirements:**




+ 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

+ 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.

+ Can assess and implement actions to ensure effective shift transition and training.



**Interactions:**




+ Manufacturing - Communicates with all levels of personnel on routine and non-routine issues. Resolves quality issues or elevates as appropriate to management. Primary shift interface with manufacturing leads/supervisor regarding quality issues, decision-making and process improvements. Actively supports operations through formal and informal meetings and actively involved with shift management to ensure a professional atmosphere and desired Company quality culture.

+ Process Group Leaders - Interacts to prioritize and process documents and resolves issues. Acts as a department/shift representative for any routine or non-routine issues.

+ Quality Engineers/Engineering - Support troubleshooting, root cause analysis, and process improvement efforts by collecting data and information on production lines. Participate in corrective action process by providing timely feedback on implemented improvements.

+ Shipping - Informs of product readiness to ship, provides necessary documentation, troubleshoots issues delaying shipment and ensures schedule requirements are met.

+ Warehouse - Communicate issues regarding materials/transactions, coordinates release of inspected materials and provides necessary documentation. Troubleshoot issues delaying material flow/ transaction and resolves routine and non-routine issues.

+ Mechanics - Informs of quality or equipment related issues, informs of facts related to process controls and primary shift interface for SPC related issues. Quality Department - Interacts with management. Acts as a key trainer of inspection processes. Demonstrates leadership skills with peer group and cross-functional teams.



**Work Environment:** The work environment characteristics are representative of a warehouse, laboratory, and manufacturing environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues and samples. Flexible work hours to meet project deadlines.



**Physical Demands:** Position requires ability to lift up to 25 lbs. on a regular basis and moving materials up to 35lbs (during line clearance and up to 50% of time spend in the dry room. Up to 60-80 of time at lab bench or desk, walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Position may require use of Personal Protective Equipment as posted.



**For Immediate Consideration, Apply Today! Questions? Call Grace at 714.253.7656 or schedule a time to connect directly follow the link:** https://calendly.com/gracepiper/15min-1






**Why Kelly** **** **?**



Kelly Science is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2020-06-10 Expires: 2020-07-11

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2nd shift Sr. Quality Control (QC) Inspector, San Diego, CA

Kelly Services
San Diego, CA 92108

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