Quality Engineer
New employees are eligible for the following benefits effective date of hire! Medical, dental, and vision benefits Company-paid life insurance and disability benefits Generous Paid time off and 10 paid Holidays 401k Plan with Company Match Tuition Reimbursement Position Scope/
Summary:
The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.
Essential Duties and
Responsibilities:
o Adheres to Viant Core Beliefs and all safety and quality requirements including, but not limited to:
Quality Management Systems (QMS), Environmental Management Systems (EMS), U.
S.
Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
o Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
o Monitors manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.
o Implements various product and process improvement methodologies.
o Review the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
o Maintains risk analysis.
o Completes protocols and reports for test method validation.
o Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies.
Recommends process monitoring devices where applicable.
o Develops various inspection techniques and procedures to ensure product integrity to design specifications.
Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.
o Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
o Effectively communicate and interact with customers.
o Participate in internal audits as a co-auditor or Lead Auditoro Completes complaint investigations.
o Executes plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
o Assists with product transfers.
o Executes capability studies and applies statistical quality control which includes Cpk, DOE, Hypotheses Testing, etc.
o Coordinates the preparation of Quality Plans, including inspection, test and gauge requirements for new product introductionso Performs other functions as required
Qualifications:
o Minimum of Associate's Degree in Engineering or related technical field, with Bachelor's Degree preferred.
o 0-3 years.
Relative co-op, internship, part-time, or classroom training experience is preferred.
Experience in medical device or regulated manufacturing a plus.
o Ability to multitask and drive initiatives to completiono Competence in the selection and use of Quality Engineering Tools and Techniques.
o Strong communication skills and ability to work in a team environment.
o Knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.
g.
FDA 21CRF820, ISO 13485:
2016, QSR, etc.
)o Proficient in Microsoft Office and Minitab It is impossible to list every requirement for, or responsibility of, any position.
Similarly, we cannot identify all the skills a position may require since job responsibilities and the Company's needs may change over time.
Therefore, the above job description is not comprehensive or exhaustive.
The Company reserves the right to adjust, add to, or eliminate any aspect of the above description.
The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.
#J-18808-Ljbffr Recommended Skills Auditing Business Process Improvement Communication Environmental Management Iso 13485 Microsoft Office Estimated Salary: $20 to $28 per hour based on qualifications.
Summary:
The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.
Essential Duties and
Responsibilities:
o Adheres to Viant Core Beliefs and all safety and quality requirements including, but not limited to:
Quality Management Systems (QMS), Environmental Management Systems (EMS), U.
S.
Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
o Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
o Monitors manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.
o Implements various product and process improvement methodologies.
o Review the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
o Maintains risk analysis.
o Completes protocols and reports for test method validation.
o Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies.
Recommends process monitoring devices where applicable.
o Develops various inspection techniques and procedures to ensure product integrity to design specifications.
Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.
o Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
o Effectively communicate and interact with customers.
o Participate in internal audits as a co-auditor or Lead Auditoro Completes complaint investigations.
o Executes plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
o Assists with product transfers.
o Executes capability studies and applies statistical quality control which includes Cpk, DOE, Hypotheses Testing, etc.
o Coordinates the preparation of Quality Plans, including inspection, test and gauge requirements for new product introductionso Performs other functions as required
Qualifications:
o Minimum of Associate's Degree in Engineering or related technical field, with Bachelor's Degree preferred.
o 0-3 years.
Relative co-op, internship, part-time, or classroom training experience is preferred.
Experience in medical device or regulated manufacturing a plus.
o Ability to multitask and drive initiatives to completiono Competence in the selection and use of Quality Engineering Tools and Techniques.
o Strong communication skills and ability to work in a team environment.
o Knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.
g.
FDA 21CRF820, ISO 13485:
2016, QSR, etc.
)o Proficient in Microsoft Office and Minitab It is impossible to list every requirement for, or responsibility of, any position.
Similarly, we cannot identify all the skills a position may require since job responsibilities and the Company's needs may change over time.
Therefore, the above job description is not comprehensive or exhaustive.
The Company reserves the right to adjust, add to, or eliminate any aspect of the above description.
The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.
#J-18808-Ljbffr Recommended Skills Auditing Business Process Improvement Communication Environmental Management Iso 13485 Microsoft Office Estimated Salary: $20 to $28 per hour based on qualifications.
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