Quality Specialist I

2 weeks ago

Auburn, United States Disability Solutions Full time
I. POSITION SUMMARY

This position is responsible for product quality analysis, disposition, and corrections. This may be done through various quality systems such as customer complaints, non-conformance reporting, and inspections. Interacts with personnel at manufacturing sites to conduct and document appropriate investigations. The person is this role may own quality management systems at the site which includes responsibilities for workflow management, metrics, training of support personnel and reporting up through management review. The person in this position must comply with the applicable regulations pertaining to the site such as FDA QSR, ISO 13485, CMDR, and any additional MDSAP regulatory requirements that pertain to the site.

II. MINIMUM KNOWLEDGE, EDUCATION AND SKILL REQUIREMENTS
  • Associates Degree or equivalent work experience.
  • 3+ years' experience with Quality Systems in a distribution/logistics environment or equivalent work experience.
  • Familiarity with FDA/QSR and/or ISO Quality System Requirements.
  • Computer proficiency, experience with common application programs - word processing, database, and spreadsheets, required.
  • Experience with SAP preferred.
  • Familiarity with the KARL STORZ line of products preferred.


III. ESSENTIAL FUNCTIONS

A. PHYSICAL REQUIREMENTS

  • Must be able to work overtime as needed.
  • Must be punctual, able to sustain attendance guidelines, and work hours as assigned.
  • The incumbent will work in a typical office environment. May need to spend significant amount of time in operational areas.
  • Eyesight sufficient to make judgments on identification and visual quality of product.
  • Must be able to spend lengthy amount of time at computer creating/searching for information.
  • Requires physical movement of product with actions such as moving, reaching, grabbing, packing, lifting, stacking, pulling, and pushing. Position requires occasional heavy lifting, up to 40 lbs.


B. MENTAL REQUIREMENTS

  • Position requires good judgment and decision making skills.
  • Position requires excellent attention to details.
  • Must be capable of making accept/reject decisions based on established procedure and criteria.
  • Must be able to recognize and bring to supervisory attention situations which may impact quality but which are not covered in established procedures.


C. 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.) One or more of the following responsibilities may be assigned at any particular time based on business needs.

  • Work to ensure processes are compliant with FDA/QSR and ISO Requirements.
  • Support quality management systems at the site which includes responsibilities for workflow management, metrics, training of support personnel and reporting up management review
  • Author procedures to clearly and effectively document processes.
  • Support and assist other departments in the creation of documented procedures.
  • Ensure compliance to established document control procedures.
  • Support all document changes per established procedures.
  • Provide final review and edit before release of documents.
  • Review documentation to ensure established processes, methods, and standards are being followed.
  • Support Change Review Board meetings.
  • Release all documentation such as drawings, specifications, procedures, work instructions, quality reports, and forms per established procedures.
  • Support training matrix and individual QSR training records.
  • Ensure compliance to established Record Retention procedures and maintain and coordinate off-site record files.
  • Maintain document hard copy library and reference center.
  • Maintain numbering system for all levels of controlled documentation.
  • Process requests for documents and change request number assignments.
  • Maintain labeling, manual, and insert reference library.
  • Review track open change requests for compliance to time limit requirement. Notify requestor of failure and need to re-issue change request.
  • Responsible for accuracy of all work, for processing documentation releases and changes in a timely manner, and for reporting quantity of change requests / orders and document releases processed on a monthly basis.
  • Complete complaint investigations as assigned.
  • Non-conformance coordination, review, investigation, and disposition.
  • Perform inspections on product related to complaint and non-conformance investigations.
  • Support periodic review of all documentation to ensure they accurately reflects current processes.
  • Maintain system for calibration of testing and measuring equipment.
  • Ensuring that all Regulatory and Quality requirements are followed as documented. This will require that the incumbent periodically monitor quality processes by attending meetings, reviewing work results, and completing spot audits.
  • Auditing forms and reports for compliance
  • Ensuring that product(s) on complaints, quality/regulatory holds, and re-inspects are processed in a timely manner with proper documentation.
  • Ensuring that KSEA Regulatory is notified of all Quality Holds issues immediately.
  • Support ensuring that all requests submitted to the Quality department are communicated and successfully resolved or transferred to the correct departments for resolution.


D. SAFETY:

  • Must not pose a direct threat or significant risk of substantial harm to the safety of himself/herself or others.
  • Must be committed to a high standard of safety and be willing and able to comply with all safety laws and all the Company's safety policies and rules. Must be willing to report safety violations and potential safety violations to appropriate supervisory or management personnel.
  • 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.


E. QUALITY

  • The incumbent in this position is generally responsible for following FDA/QSR guidelines as described in the procedures related to his/her specific job responsibilities.


F. INTERPERSONAL AND COMMUNICATION SKILLS

  • Must be able to maintain productive working relationships with co-workers.
  • Must treat fellow employees with respect.
  • Good grammatical skills are required to proof read, edit, and/or write procedures in clear, concise language.
  • Will interact with all levels of the organization to communicate needs and relay information to KARL STORZ employees located at multiple locations. May also interact with external customers and suppliers. This will require effective written and oral communication skills.
  • Must be able to adapt and demonstrate flexibility in dealing with changing priorities and work situations.
  • Must demonstrate motivation and initiative.


IV. OTHER FUNCTIONS

A. 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.)

  • Serve as a point person for problem solving and answering questions.
  • Assist with management review meetings.
  • Review labeling text revisions and new issues from Regulatory Affairs for obvious errors.
  • QSR Documentation Change Review Board.
  • Process change reviews.
  • Corrective and Preventive Action.
  • Conduct Internal Audits as part of the internal audit team.
  • Software revision control and tracking.
  • Problem resolution.
  • Other duties as assigned.


B. OTHER PHYSICAL, MENTAL, INTERPERSONAL AND COMMUNICATION REQUIREMENTS

  • Communicates with manufacturers to conduct appropriate product investigations.
  • Communicates with customers as needed to obtain information for complaint investigations


Get in Contact

  • Quality Inspector/Monitor

    3 weeks ago

    Auburn, United States O-I Full time

    Job DescriptionJob DescriptionCompany DescriptionAbout O-IRemember the last time you opened a bottle of champagne? A cold beer after a hard day’s work or a bottle of sparkling mineral water to quench your thirst? Well, it was probably made by us. We are O-I and we love that we make more glass containers than anyone in the world. O-I has more than a...

  • Manufacturing Production Specialist

    1 week ago

    Auburn, New York, United States O-I Full time

    Job OverviewCompany OverviewO-I is a global leader in glass container manufacturing, renowned for producing a wide range of high-quality glass packaging for various industries, including food and beverages. With over a century of expertise, we are committed to sustainability and innovation in our products.Why Join Us?Our facility offers a dynamic work...

  • Quality Assurance Specialist

    3 days ago

    Auburn Hills, Michigan, United States TRIGO Global Quality Solutions Full time

    Job DescriptionTRIGO Global Quality Solutions is seeking a Quality Assurance Specialist to join our team in San Antonio, TX.Job SummaryThe Quality Assurance Specialist will provide quality services and support for all missions assigned to a manufacturing or warehouse site while ensuring a healthy and safe work environment.Key ResponsibilitiesAct as an...

  • Wholesale Support Specialist I

    2 weeks ago

    Auburn, New Hampshire, United States Sullivan Tire & Auto Service Full time

    Role Overview:As a Wholesale Support Specialist I, you will be responsible for delivering exceptional service and assistance to our internal and wholesale clientele through various communication channels. Key Responsibilities:1. Engage with customers to provide up-to-date product details, pricing, and stock availability to facilitate order fulfillment.2....

  • Quality Inspectors

    3 months ago

    Auburn Hills, United States TRIGO Global Quality Solutions Full time

    Job DescriptionJob DescriptionQuality Inspectors DAILY PAY OFFERED! Opportunity to enroll in group plan coverages,1st of the month following 30 days, to include: Dental, Vision, Short-Term Disability, Life and Critical Illness Insurance. We also offer Comprehensive Medical Insurance, 401K, Vacation Pay, Safety Wear Allowance, and Referral Bonuses (all...

  • Wellness Specialist I

    5 months ago

    Auburn Hills, United States TRANSCEND COMPANY INC Full time

    Job DescriptionJob DescriptionPosition Summary:Wellness Specialist I are responsible for providing patients a dedicated point of contact to receive high quality and personalized service pertaining to the healthcare products available through Transend. The Wellness Specialist role shares qualities between that of; a Consultative Sales Rep/Account Manager, and...

  • Quality Inspectors

    1 month ago

    Auburn Hills, United States TRIGO Global Quality Solutions Full time

    Job DescriptionJob DescriptionTRIGO Global Quality Solutions has several immediate openings for Quality Inspectors in San Antonio, TX.Overall Purpose of the Quality InspectorProvide Quality services and support for all missions assigned to a manufacturing or warehouse site while ensuring a healthy and safe work environment. Reports toSite Supervisor/Site...

  • Quality Assurance Specialist

    2 days ago

    Auburn, New York, United States Chili's Grill & Bar Full time

    Job SummaryWe are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team at Chili's Grill & Bar. As a Quality Assurance Specialist, you will play a critical role in ensuring that every guest receives perfectly prepared, high-quality food and exceptional service.Key ResponsibilitiesFood Preparation and Quality Control:...

  • Quality Assurance Specialist

    5 days ago

    Auburn, Indiana, United States Continental Full time

    Job Description**About Continental**Continental is a leading technology company that develops innovative solutions for sustainable and connected mobility. With a rich history dating back to 1871, the company has grown to become a global leader in the industry.**Job Summary**We are seeking a highly skilled Quality Assurance Specialist to join our team as an...

  • Quality Assurance Specialist

    3 days ago

    Auburn Hills, Michigan, United States TRIGO Global Quality Solutions Full time

    Job DescriptionTRIGO Global Quality Solutions is seeking a Quality Inspector to join our team in Auburn Hills, MI.Job SummaryThe Quality Inspector will be responsible for providing quality services and support for all missions assigned to a manufacturing or warehouse site while ensuring a healthy and safe work environment.Key ResponsibilitiesClient...

  • Quality Control Inspector I

    2 weeks ago

    Auburn, United States Repligen Full time

    Overview The QC Inspector I report directly to the QC Inspector Lead, QA Manager or Director. This position is responsible to actively participate in the Repligen ISO 13485 Quality Management System. This role is responsible for inspecting, auditing, and reporting on incoming materials and processes using various visual techniques and measuring equipment...

  • Quality Assurance Specialist

    16 hours ago

    Auburn, Alabama, United States Disability Solutions Full time

    Job DescriptionAbout the Role:We are seeking a highly skilled Quality Assurance Specialist to join our team at Disability Solutions. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and services, while also contributing to the development and implementation of quality management systems.Key...

  • Production Shift Supervisor

    3 weeks ago

    Auburn, United States O-I Full time

    Job DescriptionJob DescriptionCompany DescriptionTo be the leading producer of glass bottles and jars worldwide you need passion, commitment and innovation baked into the very fabric of a business and its people. For more than 120 years, our glass makers have honed their craft—channeling their creativity into more than 1,800 patents held today. When you...

  • Production Operator

    3 days ago

    Auburn, New York, United States O-I Full time

    Job SummaryWe are seeking a highly motivated and safety-conscious Production Operator to join our team at O-I. As a Production Operator, you will play a critical role in ensuring the quality and efficiency of our glass manufacturing process.Key ResponsibilitiesUnderstand and adhere to carton quality requirements, performing regular checks to ensure...

  • Production Operator

    1 month ago

    Auburn, United States O-I Full time

    Job DescriptionJob DescriptionCompany DescriptionAbout O-IRemember the last time you opened a bottle of champagne? A cold beer after a hard day’s work or a bottle of sparkling mineral water to quench your thirst? Well, it was probably made by us. We are O-I and we love that we make more glass containers than anyone in the world. O-I has more than a...

  • IT Support Specialist I

    2 weeks ago

    Auburn, Maine, United States JOHN F MURPHY HOMES INC Full time

    Position Overview:The IT Support Specialist I is a proactive individual responsible for executing various Information Technology (IT) tasks to assist the organization. The main objective is to provide support to end users regarding their computing requirements in a courteous and professional manner. Key Responsibilities:Ensures confidentiality of all handled...

  • IT Support Specialist I

    1 week ago

    Auburn, Maine, United States JOHN F MURPHY HOMES INC Full time

    Position Overview:The IT Support Specialist I is a proactive individual responsible for executing various Information Technology (IT) tasks to assist the organization. The primary objective is to provide support to end users with their computing requirements in a professional and courteous manner. Key Responsibilities:Ensures confidentiality of all handled...

  • IT Support Specialist I

    1 week ago

    Auburn, Maine, United States JOHN F MURPHY HOMES INC Full time

    Position Overview:The IT Support Specialist I is a proactive individual responsible for executing various Information Technology (IT) tasks to assist the organization. The primary objective is to provide support to end users regarding their computing requirements in a professional and courteous manner. Key Responsibilities:Upholds confidentiality concerning...

  • Quality Inspectors

    1 month ago

    Auburn Hills, United States TRIGO Global Quality Solutions Full time

    Job DescriptionJob DescriptionTRIGO Global Quality Solutions has several immediate openings for Quality Inspectors in Auburn Hills, MIOverall Purpose of the Quality InspectorProvide Quality services and support for all missions assigned to a manufacturing or warehouse site while ensuring a healthy and safe work environment. Reports toSite Supervisor/Site...

  • Quality Inspectors

    4 days ago

    Auburn Hills, United States TRIGO Global Quality Solutions Full time

    Job DescriptionJob DescriptionTRIGO Global Quality Solutions has several immediate openings for Quality Inspectors in Auburn Hills, MI.Overall Purpose of the Quality InspectorProvide Quality services and support for all missions assigned to a manufacturing or warehouse site while ensuring a healthy and safe work environment. Reports toSite Supervisor/Site...