Job Description
Pay $32-34.50
6 month+ assignment possible temp to direct hire
Have working knowledge of computer systems and be comfortable learning new software. Experience with Excel, SharePoint, Propel PLM, and QAD ERP is preferred. Candidates without direct experience in these systems should be receptive to coaching and able to learn them quickly.
My preference remains a QA Tech II whose time allocation can adjust based on volume, ranging from approximately 90% supporting manufacturing and quality records, including reviewing, scanning, and filing, and 10% on receiving inspection, to a 50-50 split or 10% supporting manufacturing and quality records and 90% on receiving inspection.
SUMMARY: This experienced technician is responsible for performing tasks of moderate difficulty associated with incoming inspection and product testing while ensuring applicable product/component quality control specifications are met. An individual in this roll will assist the company in maintaining compliance to regulations, procedures, and work instructions.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
Benefits (employee contribution):
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Rate of pay within the stated range will depend on the qualification of the applicant.
6 month+ assignment possible temp to direct hire
Have working knowledge of computer systems and be comfortable learning new software. Experience with Excel, SharePoint, Propel PLM, and QAD ERP is preferred. Candidates without direct experience in these systems should be receptive to coaching and able to learn them quickly.
- Review device/lot history records, manufacturing records, and quality control records to verify that the information is accurate and complete and that all specifications and GDP requirements have been met. (QA Tech I & QA Tech II)
- Fill out, organize, reviews, maintain and archive quality control records. (QA Tech I & QA Tech II)
- Conduct visual, dimensional, and functional inspection, as directed by quality procedures and other specifications. (QA Tech II)
- Record and analyze the inspection and testing data to determine if acceptance criteria are met. (QA Tech II)
My preference remains a QA Tech II whose time allocation can adjust based on volume, ranging from approximately 90% supporting manufacturing and quality records, including reviewing, scanning, and filing, and 10% on receiving inspection, to a 50-50 split or 10% supporting manufacturing and quality records and 90% on receiving inspection.
EDUCATION/EXPERIENCE:
- A minimum of 2 years of quality control experience in the medical device industry; or equivalent combination of education/training and work experience.
- Experience working with catheters, endovascular or neurological devices (preferred)
- Understanding of basic inspection techniques.
- Ability to describe in detail observed defects and assist in the disposition activities for nonconforming material.
- Proficiency in using various measurement methods and mathematical concepts to obtain test and inspection results.
- Must be able to read drawing schematics and tolerancing symbols.
- Working knowledge about quality system requirements (FDA 21 CFR Part 820 and/or ISO 13485), as they relate to quality control processes and good manufacturing practices
- Strong communications skills (both written and verbal)
- Must be able to perform multiple tasks concurrently with accuracy
- Proficiency with Microsoft Office products
SUMMARY: This experienced technician is responsible for performing tasks of moderate difficulty associated with incoming inspection and product testing while ensuring applicable product/component quality control specifications are met. An individual in this roll will assist the company in maintaining compliance to regulations, procedures, and work instructions.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
- Conduct visual, dimensional and functional inspection, as directed by quality procedures and other specifications.
- Record and analyze the inspection and testing data to determine if acceptance criteria is met.
- Review completed production lot history records to ensure completeness and good documentation requirements have been met.
- Perform production line audits and use knowledge and judgement to ensure process steps are being followed by the production staff.
- Follow all procedures and specifications to perform assigned tasks in an accurate manner.
- Employ good documentation practices to communicate in writing all aspects of the job.
- Employ statistical sampling techniques in routine inspection and testing activities.
- Generate nonconformance reports and participate in activities taken by the organization to deal with nonconforming material.
- Participate in investigations and root cause analyses for identified issues and recommend improvement.
- Ensure equipment utilized is in good working order and within the calibration and preventative maintenance schedule.
- Proactively support continuous improvement and lean manufacturing processes.
- Review device history records, manufacturing records, and quality control records to verify that the information is accurate and complete and that all specifications and GDP requirements have been met.
- Fill out, organize, reviews, maintain and archive quality control records.
- Complete and store inspection records.
- Assist with maintaining electronic logs used for documenting inspection results.
- May assist in complaint investigations with a focus on returned device evaluation and production record review.
- Actively promote and support the Quality Management System, Quality Objectives, and Quality Policy.
- Assure that you and functional subordinates (if applicable) are trained on all applicable procedures and processes according to Good Manufacturing Practices, applicable FDA, and Regulatory requirements.
- Actively promote and support the company s Management Review process.
- Inform responsible personnel of concerns involving product quality.
- Perform job functions in a safe and effective manner.
- Other duties as assigned.
Benefits (employee contribution):
- Health insurance
- Health savings account
- Dental insurance
- Vision insurance
- Flexible spending accounts
- Life insurance
- Retirement plan
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Rate of pay within the stated range will depend on the qualification of the applicant.
Numbers & Facts
| Location | Campbell, CA |
| Industry | Staffing/Employment Agencies |
| Salary | $32–$34.50 Per Hour |
| Company Size | 50 to 99 employees |
| Year Founded | 2014 |
| Website | http://www.insyncstaffing.com/default.html |
About Company
We recognize the VMS program management team is our customer and needs to be serviced with integrity, so we built and continue to improve upon our delivery methods as we strive to provide the highest quality service possible.
inSync Staffing’s management team recognized ten years ago the inevitable changes to the staffing industry being brought about by technology and the growing trend of Fortune 1000 corporations to outsource management of their contingent workforces to meet compliance and cost control goals. Rather than swim upstream against the changes, inSync Staffing has embraced MSP and VMS programs as our customers, not competitors. We asked program managers how they want to be serviced.
The result of their input is that we have structured inSync Staffing as a recruiting and customer service organization, unlike traditional staffing companies who sell directly to the end client. Our delivery model allows us concentrates our resources on how to best supply candidates in a very competitive MSP/VMS program environment.
Skills
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