Planet Pharma
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http://www.theplanetgroup.com
http://www.theplanetgroup.com
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Target PR Range: 31-41/hr
*Depending on experience
We are seeking an experienced, high caliber Supplier Quality Engineer to be responsible for Responsible for conducting supplier audits, qualifying new suppliers, and monitoring the performance of current suppliers. Must be able to handle supplier audit situations and interactions in a tactful, professional and effective manner. Each employee can make a difference at and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
You will drive qualification of suppliers and monitoring of suppliers. You will provide technical support in the selection and development of suppliers. You’ll monitor supplier performance to drive supplier corrective action, manufacturing yield issues and field failures and be responsible for maintaining compliance with applicable Corporate and Divisional Policies and procedures.
Your main responsibilities will include:
• Supplier Audits: Develop and execute to a supplier audit schedule per current requirements.
• Develop audit plans and associated supplier communications.
• Approve and monitor Supplier CAPA plans and activities to closure including objective evidence of effectiveness.
• ISO lead auditor certification or equivalent is preferred.
• Qualify and then monitor supplier performance Per current requirements perform activities that will qualify new suppliers and monitor current supplier base to ensure the status of the suppliers is correct.
• Work with suppliers as needed to ensure their performance is acceptable per site requirements.
• Work with Design and Development, Manufacturing, Purchasing and IQA when qualifying and monitoring supplier performance.
• CAPA Through the supplier audits and internal issues with supplier product, issue SCARs for supplier corrective/preventive action activities.
• Analyze Supplier information and present supplier metrics to appropriate CAPA boards.
• Demonstrated writing and communication skills are required for this position.
• A thorough understanding of the ISO/QSRs and the ability to apply that knowledge with an understanding of business operations to achieve regulatory compliance is needed.
• Must be able to explain audit results and influence other's understandings of audit observations in a tactful and professional manner.
• Knowledge of regulations and standards affecting in vitro diagnostic's device manufacturing.
Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. May lead a project team of moderate scope. Provides guidance to less experienced staff. BS degree in engineering or related scientific field plus 5-8 years of related work experience with a good understanding of specified functional area, or Master's degree with 0-2 years of related work experience.
EDUCATION AND EXPERIENCE YOU’LL BRING
REQUIRED
• Bachelor’s degree in Engineering or Technical Field or equivalent experience
• 5 years of related experience
• Engineering experience and demonstrated use of Quality tools/methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
• Solid communication and interpersonal skills.
• Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Ability to travel approximately 40%
PREFERRED
• Master’s degree preferred
• Prior medical device experience preferred.
• Demonstrated supervisory experience preferred.
• ASQ CQE or other certifications preferred.
• Experience working in a broader enterprise/cross-division business unit model preferred.
Supplier Quality Engineer
387 Technology Circle Northwest Atlanta, GA 30313 US
Posted: 06/01/2023
2023-06-01
2023-07-07
Employment Type:
Contract
Job Category: Engineering
Job Number: 566634
Is job remote?: No
Country: United States
Job Description
Target PR Range: 31-41/hr
*Depending on experience
We are seeking an experienced, high caliber Supplier Quality Engineer to be responsible for Responsible for conducting supplier audits, qualifying new suppliers, and monitoring the performance of current suppliers. Must be able to handle supplier audit situations and interactions in a tactful, professional and effective manner. Each employee can make a difference at and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
You will drive qualification of suppliers and monitoring of suppliers. You will provide technical support in the selection and development of suppliers. You’ll monitor supplier performance to drive supplier corrective action, manufacturing yield issues and field failures and be responsible for maintaining compliance with applicable Corporate and Divisional Policies and procedures.
Your main responsibilities will include:
• Supplier Audits: Develop and execute to a supplier audit schedule per current requirements.
• Develop audit plans and associated supplier communications.
• Approve and monitor Supplier CAPA plans and activities to closure including objective evidence of effectiveness.
• ISO lead auditor certification or equivalent is preferred.
• Qualify and then monitor supplier performance Per current requirements perform activities that will qualify new suppliers and monitor current supplier base to ensure the status of the suppliers is correct.
• Work with suppliers as needed to ensure their performance is acceptable per site requirements.
• Work with Design and Development, Manufacturing, Purchasing and IQA when qualifying and monitoring supplier performance.
• CAPA Through the supplier audits and internal issues with supplier product, issue SCARs for supplier corrective/preventive action activities.
• Analyze Supplier information and present supplier metrics to appropriate CAPA boards.
• Demonstrated writing and communication skills are required for this position.
• A thorough understanding of the ISO/QSRs and the ability to apply that knowledge with an understanding of business operations to achieve regulatory compliance is needed.
• Must be able to explain audit results and influence other's understandings of audit observations in a tactful and professional manner.
• Knowledge of regulations and standards affecting in vitro diagnostic's device manufacturing.
Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. May lead a project team of moderate scope. Provides guidance to less experienced staff. BS degree in engineering or related scientific field plus 5-8 years of related work experience with a good understanding of specified functional area, or Master's degree with 0-2 years of related work experience.
EDUCATION AND EXPERIENCE YOU’LL BRING
REQUIRED
• Bachelor’s degree in Engineering or Technical Field or equivalent experience
• 5 years of related experience
• Engineering experience and demonstrated use of Quality tools/methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
• Solid communication and interpersonal skills.
• Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Ability to travel approximately 40%
PREFERRED
• Master’s degree preferred
• Prior medical device experience preferred.
• Demonstrated supervisory experience preferred.
• ASQ CQE or other certifications preferred.
• Experience working in a broader enterprise/cross-division business unit model preferred.
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