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Description
Position Summary:
Conduct QC Incoming Inspection of components and raw materials (ensuring that materials meet
specifications), In-Process audits (ensuring that manufacturing operations remain in control), and the
inspection and release of finished product, as appropriate. Ensure equipment is maintained / calibrated as appropriate, departmental documentation is current and accurate. Responsible for ensuring deviations are properly documented and nonconforming material is segregated and secured. Performs all duties using safety conscious practices. Individual must inspect/test/audit materials & processes in a timely fashion while ensuring conformance to all requirements.
Primary Duties:
1. Perform a wide variety of inspection, audit and release activities.
2. Written procedures, blueprints, standards and regulations that define requirements assume a
significant degree of experience and understanding on the part of the QC Technician of inspection
techniques, appropriate inspection equipment, principles of sampling, auditing, and the theory of
operation and function of the various instruments.
3. Inherent in the process of inspection is the interpretation of requirements, and the need to use careful judgment to determine compliance. Consistent decision-making is required.
4. Perform QC testing which routinely results in the need to investigate nonconformances, and either
independently address them, or interface with technicians and/or engineers to diagnose and remedy
the problem.
5. Understand operational priorities, "hot parts" lists, and the daily/weekly instrument production schedule to meet the needs.
6. Responsible for the timely setup and inspection of components, raw materials, in-process, and release
of finished product in accordance with specifications. Interprets blueprint requirements and confirms
conformance to specifications.
7. Transport conforming parts to inventory, including all computer transactions and written record
completion. For materials found to be nonconforming, generates "nonconforming material reports",
requiring a technically accurate description of the anomalies.
8. Responsible for ensuring nonconforming, Line Throw Off, and Purged material is segregated and
secured including the disposition of non-conforming materials meet all necessary site and regulatory
requirements.
9. Perform Quality Control in-process inspections & audits necessary to support Instrument
Manufacturing. Assesses subassemblies, finished devices, and the assembly & test processes for
conformance to documented requirements.
10. Perform final inspections of completed medical devices and accessories, including the detailed review of the Device History Record package to confirm the completeness and accuracy of records prior to formally releasing the instrument for distribution.
11. Execute basic First Article Inspections.
12. Responsible for ensuring that QC Inspection Methods are current and accurate.
13. Maintains an understanding of all specifications, requirements, and procedures adequately to provide input regarding the continuous improvement of each.
KNOWLEDGE, EXPERIENCE & SKILLS
Highest level education required (must be job-related). Identify the discipline, where applicable:
Vocational/Technical
Will work experience be accepted in lieu of a degree? Yes
If yes, number of years' experience accepted in lieu of degree and type:
2 years experience in a Quality Department will be accepted in lieu of the degree, in addition to other requirements
List / describe specific work experience requirements and/or skills:
1. Requires a Technical degree and 2 years of work experience, or 4 years of work experience in a
Quality Control setting having basic knowledge of quality systems (SAP/LIMS/Trackwise).
2. Ability to effectively communicate written and verbally.
3. Requires strong interpersonal skills to interact with all levels of the organization and consistent decision making. Also requires a solid analytical approach to decision making and problem solving.
4. Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
5. Must have a knowledge of the interpretation and application of relevant Domestic and International
Regulations and Industry Standards (ISO, QSR, UL, CSA, VDE, etc.).
6. Experienced in the ability to read and interpret complex blueprints, a plus would be the knowledge of Geometric Dimensioning & Tolerancing (GD&T).
7. Ability to work with limited supervision and to complete tasks in a timely fashion.
Supervisory Responsibilities: N/A
IMPACT / MANAGEMENT SCOPE
Decision making or problem solving authority: Basic
This position impacts the manufacturing life cycle Quality Control for products produced in St. Louis. Failure to properly execute Quality Control inspections, tests, or analyses on the part of this position could directly result in a product recall. Operating within clearly defined guidelines, is empowered to make decisions impacting product quality, quality records, deviation resolution, and site compliance.
Decision making authority below:
Decisions with long term impact - With supervisory review/approval required
Decisions with short term impact- With supervisory review/approval required
If applicable, please include the following:
Revenue Size: N/A
Sales Volume: N/A
Operating Budget: N/A
Working conditions:
Domestic travel require - <5% of time
Typical office setting
Manufacturing / Operations Center
Physical requirements:
Must be able to push a wheeled cage that can weigh up to 600lbs. May operate within cool temperatures and low humidity. Constant noise is common due to equipment. Occasional environmental odors may be present. Excellent personal hygiene and appropriate gowning required in production and laboratory areas.
Lifting 25-50lbs
Pushing 150+ lbs
Pulling 150+ lbs
Bending
Walking 25%
Standing 25%
Sitting 50%
Typing 25%
BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics' application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).
Description
Position Summary:
Conduct QC Incoming Inspection of components and raw materials (ensuring that materials meet
specifications), In-Process audits (ensuring that manufacturing operations remain in control), and the
inspection and release of finished product, as appropriate. Ensure equipment is maintained / calibrated as appropriate, departmental documentation is current and accurate. Responsible for ensuring deviations are properly documented and nonconforming material is segregated and secured. Performs all duties using safety conscious practices. Individual must inspect/test/audit materials & processes in a timely fashion while ensuring conformance to all requirements.
Primary Duties:
1. Perform a wide variety of inspection, audit and release activities.
2. Written procedures, blueprints, standards and regulations that define requirements assume a
significant degree of experience and understanding on the part of the QC Technician of inspection
techniques, appropriate inspection equipment, principles of sampling, auditing, and the theory of
operation and function of the various instruments.
3. Inherent in the process of inspection is the interpretation of requirements, and the need to use careful judgment to determine compliance. Consistent decision-making is required.
4. Perform QC testing which routinely results in the need to investigate nonconformances, and either
independently address them, or interface with technicians and/or engineers to diagnose and remedy
the problem.
5. Understand operational priorities, "hot parts" lists, and the daily/weekly instrument production schedule to meet the needs.
6. Responsible for the timely setup and inspection of components, raw materials, in-process, and release
of finished product in accordance with specifications. Interprets blueprint requirements and confirms
conformance to specifications.
7. Transport conforming parts to inventory, including all computer transactions and written record
completion. For materials found to be nonconforming, generates "nonconforming material reports",
requiring a technically accurate description of the anomalies.
8. Responsible for ensuring nonconforming, Line Throw Off, and Purged material is segregated and
secured including the disposition of non-conforming materials meet all necessary site and regulatory
requirements.
9. Perform Quality Control in-process inspections & audits necessary to support Instrument
Manufacturing. Assesses subassemblies, finished devices, and the assembly & test processes for
conformance to documented requirements.
10. Perform final inspections of completed medical devices and accessories, including the detailed review of the Device History Record package to confirm the completeness and accuracy of records prior to formally releasing the instrument for distribution.
11. Execute basic First Article Inspections.
12. Responsible for ensuring that QC Inspection Methods are current and accurate.
13. Maintains an understanding of all specifications, requirements, and procedures adequately to provide input regarding the continuous improvement of each.
KNOWLEDGE, EXPERIENCE & SKILLS
Highest level education required (must be job-related). Identify the discipline, where applicable:
Vocational/Technical
Will work experience be accepted in lieu of a degree? Yes
If yes, number of years' experience accepted in lieu of degree and type:
2 years experience in a Quality Department will be accepted in lieu of the degree, in addition to other requirements
List / describe specific work experience requirements and/or skills:
1. Requires a Technical degree and 2 years of work experience, or 4 years of work experience in a
Quality Control setting having basic knowledge of quality systems (SAP/LIMS/Trackwise).
2. Ability to effectively communicate written and verbally.
3. Requires strong interpersonal skills to interact with all levels of the organization and consistent decision making. Also requires a solid analytical approach to decision making and problem solving.
4. Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
5. Must have a knowledge of the interpretation and application of relevant Domestic and International
Regulations and Industry Standards (ISO, QSR, UL, CSA, VDE, etc.).
6. Experienced in the ability to read and interpret complex blueprints, a plus would be the knowledge of Geometric Dimensioning & Tolerancing (GD&T).
7. Ability to work with limited supervision and to complete tasks in a timely fashion.
Supervisory Responsibilities: N/A
IMPACT / MANAGEMENT SCOPE
Decision making or problem solving authority: Basic
This position impacts the manufacturing life cycle Quality Control for products produced in St. Louis. Failure to properly execute Quality Control inspections, tests, or analyses on the part of this position could directly result in a product recall. Operating within clearly defined guidelines, is empowered to make decisions impacting product quality, quality records, deviation resolution, and site compliance.
Decision making authority below:
Decisions with long term impact - With supervisory review/approval required
Decisions with short term impact- With supervisory review/approval required
If applicable, please include the following:
Revenue Size: N/A
Sales Volume: N/A
Operating Budget: N/A
Working conditions:
Domestic travel require - <5% of time
Typical office setting
Manufacturing / Operations Center
Physical requirements:
Must be able to push a wheeled cage that can weigh up to 600lbs. May operate within cool temperatures and low humidity. Constant noise is common due to equipment. Occasional environmental odors may be present. Excellent personal hygiene and appropriate gowning required in production and laboratory areas.
Lifting 25-50lbs
Pushing 150+ lbs
Pulling 150+ lbs
Bending
Walking 25%
Standing 25%
Sitting 50%
Typing 25%
BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics' application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).
