Katalyst CRO
Supplier Quality
Katalyst CRO - Minneapolis, Minnesota, United States, 55400
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Overview
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Supplier Quality
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Katalyst CRO 8 months ago Be among the first 25 applicants Join to apply for the
Supplier Quality
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Katalyst CRO Lead the supplier qualification process by assessing manufacturing/technology capabilities. Conduct comprehensive gap assessments at target suppliers to identify areas for improvement and create individual supplier development plans. Work with suppliers and run SCN and PPAP activity. Develop and refine comprehensive training materials to effectively deploy problem-solving, process control, and quality tools. Proactively identify and implement continuous improvement activities to prevent the recurrence of non-conformities, ensuring sustained process enhancements. Review supplier manufacturing processes and collaborate with suppliers on process improvement and value enhancement opportunities. Facilitate root cause analysis and corrective actions of supplier quality issues. I independently work with suppliers for the completion of PPAP, Special Process Validation IQ, OQ and PQ requirements. Knowledge of International standards relative to QMS, ISO 9001:2015, ISO 13485, and ASTM/ASME standards are preferred. Strong knowledge of Supplier Qualification, Supplier Production Part Approval Process (SPPA), conducting Product and Process Audit at the supplier end Tailor strategies based on supplier and activity feedback to ensure maximum deployment effectiveness. Collaborate with cross-functional teams to develop and enhance the overall supplier development process and phased rollout plans. Facilitate the escalation of unresolved supplier quality issues within assigned projects and suppliers and deliver quality awareness training to suppliers. Monitor supplier progress and performance against pre-agreed objectives and goals, providing guidance and support as needed.
Responsibilities
Lead the supplier qualification process by assessing manufacturing/technology capabilities. Conduct comprehensive gap assessments at target suppliers to identify areas for improvement and create individual supplier development plans. Work with suppliers and run SCN and PPAP activity. Develop and refine comprehensive training materials to effectively deploy problem-solving, process control, and quality tools. Proactively identify and implement continuous improvement activities to prevent the recurrence of non-conformities, ensuring sustained process enhancements. Review supplier manufacturing processes and collaborate with suppliers on process improvement and value enhancement opportunities. Facilitate root cause analysis and corrective actions of supplier quality issues. I independently work with suppliers for the completion of PPAP, Special Process Validation IQ, OQ and PQ requirements. Knowledge of International standards relative to QMS, ISO 9001:2015, ISO 13485, and ASTM/ASME standards are preferred. Strong knowledge of Supplier Qualification, Supplier Production Part Approval Process (SPPA), conducting Product and Process Audit at the supplier end Tailor strategies based on supplier and activity feedback to ensure maximum deployment effectiveness. Collaborate with cross-functional teams to develop and enhance the overall supplier development process and phased rollout plans. Facilitate the escalation of unresolved supplier quality issues within assigned projects and suppliers and deliver quality awareness training to suppliers. Monitor supplier progress and performance against pre-agreed objectives and goals, providing guidance and support as needed.
Requirements
Bachelor's degree in engineering B. Tech / B.E preferred (E.g., Mechanical Engineering or equivalent) or a related field. 5-10 years of experience in Supplier Quality Engineering, preferably in the Medical Device Industry. Language Proficiency. Strong ability in interpreting engineering drawings/prints. Proficiency in quality tools, risk analysis and statistical tools for problem-solving. Willingness and ability to undertake travel at the supplier end on a need basis. Exceptional verbal, written, presentation, and interpersonal skills. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Job function Quality Assurance Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Supplier Quality Specialist jobs in
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Supplier Quality
role at
Katalyst CRO 8 months ago Be among the first 25 applicants Join to apply for the
Supplier Quality
role at
Katalyst CRO Lead the supplier qualification process by assessing manufacturing/technology capabilities. Conduct comprehensive gap assessments at target suppliers to identify areas for improvement and create individual supplier development plans. Work with suppliers and run SCN and PPAP activity. Develop and refine comprehensive training materials to effectively deploy problem-solving, process control, and quality tools. Proactively identify and implement continuous improvement activities to prevent the recurrence of non-conformities, ensuring sustained process enhancements. Review supplier manufacturing processes and collaborate with suppliers on process improvement and value enhancement opportunities. Facilitate root cause analysis and corrective actions of supplier quality issues. I independently work with suppliers for the completion of PPAP, Special Process Validation IQ, OQ and PQ requirements. Knowledge of International standards relative to QMS, ISO 9001:2015, ISO 13485, and ASTM/ASME standards are preferred. Strong knowledge of Supplier Qualification, Supplier Production Part Approval Process (SPPA), conducting Product and Process Audit at the supplier end Tailor strategies based on supplier and activity feedback to ensure maximum deployment effectiveness. Collaborate with cross-functional teams to develop and enhance the overall supplier development process and phased rollout plans. Facilitate the escalation of unresolved supplier quality issues within assigned projects and suppliers and deliver quality awareness training to suppliers. Monitor supplier progress and performance against pre-agreed objectives and goals, providing guidance and support as needed.
Responsibilities
Lead the supplier qualification process by assessing manufacturing/technology capabilities. Conduct comprehensive gap assessments at target suppliers to identify areas for improvement and create individual supplier development plans. Work with suppliers and run SCN and PPAP activity. Develop and refine comprehensive training materials to effectively deploy problem-solving, process control, and quality tools. Proactively identify and implement continuous improvement activities to prevent the recurrence of non-conformities, ensuring sustained process enhancements. Review supplier manufacturing processes and collaborate with suppliers on process improvement and value enhancement opportunities. Facilitate root cause analysis and corrective actions of supplier quality issues. I independently work with suppliers for the completion of PPAP, Special Process Validation IQ, OQ and PQ requirements. Knowledge of International standards relative to QMS, ISO 9001:2015, ISO 13485, and ASTM/ASME standards are preferred. Strong knowledge of Supplier Qualification, Supplier Production Part Approval Process (SPPA), conducting Product and Process Audit at the supplier end Tailor strategies based on supplier and activity feedback to ensure maximum deployment effectiveness. Collaborate with cross-functional teams to develop and enhance the overall supplier development process and phased rollout plans. Facilitate the escalation of unresolved supplier quality issues within assigned projects and suppliers and deliver quality awareness training to suppliers. Monitor supplier progress and performance against pre-agreed objectives and goals, providing guidance and support as needed.
Requirements
Bachelor's degree in engineering B. Tech / B.E preferred (E.g., Mechanical Engineering or equivalent) or a related field. 5-10 years of experience in Supplier Quality Engineering, preferably in the Medical Device Industry. Language Proficiency. Strong ability in interpreting engineering drawings/prints. Proficiency in quality tools, risk analysis and statistical tools for problem-solving. Willingness and ability to undertake travel at the supplier end on a need basis. Exceptional verbal, written, presentation, and interpersonal skills. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Job function Quality Assurance Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Supplier Quality Specialist jobs in
Minneapolis, MN . St Paul, MN $111,300.00-$222,700.00 1 week ago Supplier Quality Lead – Global Manufacturing
Minneapolis, MN $100,000.00-$115,000.00 3 weeks ago Sr. Supplier Development Quality Engineer
St Paul, MN $75,300.00-$150,700.00 1 week ago Greater Minneapolis-St. Paul Area $82,300.00-$152,800.00 1 week ago Minneapolis, MN $97,962.00-$126,775.00 2 weeks ago Minneapolis, MN $73,800.00-$98,333.00 1 week ago Bloomington, MN $86,200.00-$122,000.00 4 days ago St Paul, MN $60,000.00-$120,000.00 2 weeks ago Minneapolis, MN $100,000.00-$115,000.00 2 days ago Supplier Development Quality Engineer II
St Paul, MN $60,000.00-$120,000.00 3 days ago Supplier Quality Engineering Lead/Supervisor
Minneapolis, MN $100,000.00-$115,000.00 4 weeks ago Minneapolis, MN $97,962.00-$126,775.00 2 weeks ago Minneapolis, MN $45.00-$55.00 10 hours ago Minneapolis, MN $105,000.00-$135,000.00 3 weeks ago St Paul, MN $90,000.00-$100,000.00 3 weeks ago Fridley, MN $70,000.00-$90,000.00 1 week ago Principal Engineer Supplier Quality - R10193191
Plymouth, MN $95,800.00-$143,600.00 2 months ago Arden Hills, MN $82,600.00-$156,900.00 1 month ago Minneapolis, MN $105,000.00-$135,000.00 1 week ago Bloomington, MN $85,000.00-$95,000.00 2 months ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr