What are the responsibilities and job description for the Quality Tech II, Night Shift (D) position at Embecta?
embecta, formerly part of BD, is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visit embecta.com.
embecta, formerly part of BD, is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visit embecta.com.
- Competitive starting rates and $2000 Welcome Bonus ($1000 at 6 months, $1000 at 12 months)
- Climate-controlled facility and many benefits including medical, dental, vision, life and disability insurance as well as 401(k) options.
D Shift: 6:20p - 6:30a
JG1
Essential Responsibilities (included but are not limited to):
- Give direction concerning product quality using quality documentation.
- Work with Team Leaders and Quality Engineers to ensure QNs are handled properly.
- Work with Quality Engineers and manufacturing to improve quality and reduce QNs.
- Complete ZE, ZM and AV notifications completely and accurately within the SAP system.
- No supervision of others
- Provide training to associates regarding product sort or rework activities as Temporary Inspection Plans as necessary.
- Assist with making changes to documents within SAP as necessary. Utilize SAP/Flexnet for product hold and release.
- Perform Device History Record review and acceptance activities according to approved quality system documentation.
- Understand, use and enforce ISO Standards and FDA regulations. Read, interpret and explain specifications and drawings as required.
- Train and certify co-workers in inspection techniques and using gages for inspection.
- Work flexible hours to support manufacturing. Maintain the accurate filing of DHR documentation.
- Maintain the accurate filing of Change Control Documents (EWO), validations, TIPS, etc.
- Knowledge of the linkages associated with the administration of the quality system records.
- Maintain paper record files onsite and offsite (as required) to prevent deterioration and facilitate look up and/or recovery.
- These records include: DHR, Validations, TMV’s, EWO’s, FAT’s, SCR’s, ACR’s, etc.
- Knowledge of Sterilization/Warehouse procedures (label control, bar code, scheduling of product, etc.)
- Provides key support to validation activities.
- Provide tracking of the components, subassemblies, and finished goods associated with validation product.
- Provide final review of DHR records associated with any validation product identified as approved for release.
- Support completion of EWO activities as directed to ensure all documentation is completed and filed appropriately.
- Support internal and external audits as necessary.
- Provide key support to electronic record conversion both from transference of paper records to creation of records electronically.
- In some cases, manage the work being performed in non-conforming product sort areas.
- Performs other duties as assigned by the Team Leader and required to support the needs of the business.
- Responsibilities listed in this description do not restrict the addition or deletion of any other responsibilities to this position.
- To perform this job successfully, the incumbent will possess the abilities or aptitudes to perform each duty successfully.
- Obey all safety programs, policies & regulations;
- Follow all GMP/QSR rules;
- Cooperate fully with the safety and environment programs;
- Ability to work in a team environment and fully cooperate with co-workers and management;
- May not pose a direct threat or significant risk to themselves or others;
- Must have regular attendance.
BASIC REQUIREMENTS:
- High school Diploma or GED
- Read, write, and speak English
- Computer Skills Required for Position: Basic Keyboarding and navigational skills, Microsoft Office, MES, SAP and Flexnet.
- proficient looking up Quality specifications;
- proficient using precision measuring instruments and able to give direction to others;
- proficient with embecta's inspection methods and documentation;
- proven interpersonal and communication (verbal and written) skills;
- demonstrated problem solving and decision-making skills;
- well developed planning, organization and prioritization skills;
- detail oriented;
- able to work with minimal direction/supervision
- High speed manufacturing environment. Must remain alert and focused.
- Regular attendance.
PREFERRED REQUIREMENTS:
- Associates Degree (Major: Manufacturing, Quality or related field)
- 2 years Medical Device manufacturing experience
embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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