Team Lead, Quality Inspection

Job Description

POSITION SUMMARY:

Responsible for maintaining quality, overseeing line stops, monitoring and coordinating the necessary resources to ensure that hour to hour production adheres to all Quality, Delivery, Cost and Safety standards. It is expected that this position will work in the operation for a minimum of 50% of the time and is expected to know all of the functions within the area they lead

MINIMUM KNOWLEDGE, EDUCATION AND SKILL REQUIREMENTS:

• Minimum of 5 years in Quality Control or Manufacturing
• High school graduate or equivalent.
• Ability to read and interpret engineering drawings, procedures and sampling plans.
• Knowledgeable in various inspection techniques, including visual inspection (using a microscope), performing variable and attribute mechanical/dimensional measurements, optics inspection and electronic/safety testing and inspection desired.
• Formal training in inspection techniques, such as CQM certification or equivalent preferred.
• Previous experience with medical devices and QSR/ISO requirements desirable.
• Experience with computer data entry.
• Computer literacy and experience with in-house applications (Excel)
• Experience in SAP preferred
• Prior knowledge of and the capability to perform/learn all jobs within the area of oversight.

ESSENTIAL FUNCTIONS
PHYSICAL REQUIREMENTS:

• Must be able to work overtime as needed.
• Must be punctual, able to sustain attendance guidelines, and work hours as assigned.
• Regular and predictable attendance and proper notification/communication in the event of absence or tardiness.
• Moderate lifting of objects up to 50lbs. Lifting up to 70lbs. (with assistance) may be required on occasion.
• Some inspection functions may require standing for extended periods of time.
• Some inspection functions may require viewing under microscope for long periods of time.
• Visual acuity of 20/25 in the better eye with or without correction in order to make judgments on visual quality of optical and other devices.
• Work environment ranges from typical room ambient conditions of temperature and humidity to typical warehouse conditions, with uncontrolled temperature and humidity.

MENTAL REQUIREMENTS:

• Capable of making accept/reject decisions based on both established procedural criteria and subjective criteria.
• Able to communicate, in both written and verbal format, clearly and concisely with personnel at all levels of the organization and on occasion, with external customers and suppliers.
• Exceptional organization skills and attention to detail. Product is serialized and maintenance of product Device History Record documentation is important.
• Ability to produce high quality work in a fast-paced work environment.
• Must have the ability to provide guidance and coaching to associates to ensure all procedures, standards and other related tasks are completed.

DUTIES AND RESPONSIBILITIES (Other duties consistent with the general nature and focus of the position and/or the goals and objectives of the department may be assigned.)

People:

• All employees are expected to be knowledgeable about and follow the Company's Equal Employment and Affirmative Action Policies, including policies on the rights of individuals with disabilities and harassment.
• Coaches and trains associates to ensure compliance with all SOPs as well as Quality, Delivery, and other standards.
• Displays a high degree of teamwork, including completion of co-workers' tasks. On occasion, willing to work in other departments.
• Trains or coordinates the training of coworkers, new-hires, or other employees to perform Inspection steps or other tasks related to supporting the work cell/department.
• Able to prioritize associates workstation based on business need.
• Creates weekly schedule for associates' assignments by Task.

Quality/Regulatory:

• Oversees the quality, delivery, and cost of the hour to hour production for 4-8 associates.
• Monitors and reports on defects and abnormalities in quality and delivery.
• Tracks department metrics.
• Coordinates daily 5S activities.
• Responsible for line stops under 10 minutes, investigates root cause of line stoppage and takes appropriate action to initiate continuous improvements.
• Responsible for escalating line stoppage issues to the supervisor/engineer.
• Responsible for ensuring equipment is undergoes Calibration / PM per due date.
• Performs routine audits of benchtop equipment for compliance.
• Ensures all SOP's and standards are followed.
• Aware of practices and processes utilizing current management tools.

Delivery:

• Coordinates resources and materials to ensure takt times are maintained. Takes appropriate actions to address any defects.
• Assembles product associated with department production needs.
• Completes SAP transactions, resolves discrepancies and material transfers.
• Completes daily and post shift check list.
• In compliance with established procedures, the position requires the completion of all tracking, inventory, processing, and safety documentation.
• Verify / audit Device History Records for compliance to GDP.

Cost:

• Oversees cycle count and internal stock card systems.
• Maintains department metrics (i.e., Production board, WIP, Daily Output, etc.)
• Able to recognize areas of waste within the inspection systems and share this with the department supervisor, manager, engineer.

ENVIRONMENT, HEALTH AND SAFETY:

• Must be committed to a high standard of safety and be willing and able to comply with all environmental and safety laws and regulations, including the Company's environmental and safety policies and procedures. Must be willing to report actual and potential environmental and safety violations to appropriate supervisory and/or management personnel.
• The incumbent in this position is responsible for knowledge of and adherence to environmental policies and company procedures as they relate to ISO 14001.
• Must not pose a direct threat or significant risk of substantial harm to the safety of himself/herself or others.
• Responsible for informing the Company if he/she is taking medications or if there are any other circumstances that would interfere with safe performance of job duties.
• The individual is explicitly responsible to read, understand, and follow all MSDSs and procedures.
• Must conduct numerous cleaning operations with solvents.

QUALITY:

• The incumbent in this position is responsible for knowledge of and adherence to the policies and procedures as they relate to the requirements of FDA Quality System Regulation, and ISO 13485.

INTERPERSONAL AND COMMUNICATION SKILLS:

• Must be able to maintain productive working relationships with co-workers.
• Must treat fellow employees with respect.
• Able to escalate atypical non-conformances to management.
• A high degree of written and verbal skill is required to conduct daily department responsibilities.
• Excellent interpersonal skills.
• Ability to train and coach associates in production related activities.

OTHER FUNCTIONS:
OTHER DUTIES AND RESPONSIBILITIES (Other duties consistent with the general nature and focus of the position and/or the goals and objectives of the department may be assigned.)

• Review of quality and repair records and review and maintenance of inspection and device history records.
• Coordination of and participation in MRB activities.
• Transaction entry in SAP inventory application.
• Daily entry in applicable databases.
• Daily cleaning duties.

OTHER PHYSICAL, MENTAL, INTERPERSONAL AND COMMUNICATION REQUIREMENTS:

• Individuals may be required to train during other shift hours

#LI-BL1

Your Benefits

• Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too*
• 3 weeks vacation, 11 holidays plus paid sick time*
• Up to 8 weeks of 100% paid company parental leave**
• 401(k) retirement savings plan providing a match of 60% of the employee's first 6% contribution (up to IRS limits)
• Section 125 Flexible Spending Accounts
• Life, STD, LTD & LTC Insurance
• We prepay your tuition up to $5,250 per year - Tuition pre-imbursement
• Fitness reimbursement of up to $200 annually
• Employee referral program of up to $2,000 per hire
• And much more

*Field sales, internships, and part-time employees are not eligible except where required by state law.
Non-employees, including temporary workers and consultants, are not eligible to participate in the KARL STORZ benefits program.
**To include, maternal/paternal leave, adoption, and fostering of a child.

KARL STORZ reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship. Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor. Employees must comply will all applicable KARL STORZ policies and procedures.

Credentialing requirements at KARL STORZ

KARL STORZ is committed to maintaining a safe work environment for our employees and customers. Most field-based roles at KARL STORZ require hospital credentialing/health screens as a condition of employment. Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers. During the interview process, we encourage you to ask how credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.

Pay Transparency

The pay range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future. When determining a specific team member's base salary and/or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.

Equal Employment Opportunity & Reasonable Accommodation Statement

KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences. To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status, or any other protected characteristic. KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at taoperations@karlstorz.com.

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