Planet Pharma
Overview
This role is for a Senior National Recruiter at Planet Pharma. The Quality Engineer role supports supplier development and the manufacturing of components and parts for Class I, II, and III medical devices. Commodities include electronics, molding, electro-mechanical, and mechanical industries. The role ensures design-for-manufacturing excellence (DfX) in the supply chain, qualifies new suppliers, and establishes sourcing links upon successful part qualification. The Quality Engineer also serves as a technical liaison between R&D, Supplier Quality, Commercial Operations, and suppliers, supporting inspection, validation, and documentation activities to meet regulatory standards. Key Responsibilities
Collaborate with R&D and engineering teams to evaluate new suppliers and components. Assess technical and manufacturing capabilities of prospective suppliers. Define technical requirements, tests, and documentation for sourced products. Subject matter expertise
PCBA manufacturing Electro-mechanical assembly Machining/metal forming Plastics molding Support supplier validations and qualifications, ensuring consistent product quality. Conduct measurement system analysis (MSA) at suppliers and align control plans with Receiving Inspection. Investigate and resolve supplier-related nonconformances. Manage Supplier Change Notifications, coordinating reviews of supplier and internal specification changes. Align supplier development and qualification processes with the Supplier Quality program. Maintain accuracy of the Approved Supplier List (ASL). Support supplier technical and process assessments using performance data. Assist with Supplier Corrective Action Requests (SCAR) and Supplier Notifications (SN). Review documentation to support supplier changes and work directly with suppliers to resolve quality issues. Additional Duties
Prepare and file PPAP documentation. Initiate First Article Inspection (FAI) forms and coordinate inspection activities with QA. Contribute to cross-functional projects across R&D, Operations, Production, Engineering, Clinical, and Regulatory teams. Qualifications
Education
Bachelor’s degree in Engineering (Mechanical, Electrical, Industrial preferred) required. Master’s degree in Engineering or related field preferred. Experience
5–8 years in a production or engineering environment (or 3–5 years with a Master’s). 3–5 years in medical device or other semi-regulated industries. Proven ability to coach and guide team members. Knowledge, Skills & Abilities
Strong technical knowledge in plastics/polymer molding, alloy machining and forming, and electronics/electro-mechanical assembly. Experience with product and process validation. Deep understanding of medical device manufacturing requirements. Proficiency in process capability and statistical data analysis. Working knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971. Familiarity with FDA process validation. ASQ certifications (CQA, CBA, CQE) preferred. Excellent documentation skills, attention to detail, and accuracy. Strong communication skills (written and oral) and ability to work cross-functionally. Highly organized, proactive, and collaborative team player. Ability to constructively challenge the status quo. Seniority level
Mid-Senior level Employment type
Full-time Job function
Engineering and Quality Assurance Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing Note: This posting may include location-specific salary information and related postings.
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This role is for a Senior National Recruiter at Planet Pharma. The Quality Engineer role supports supplier development and the manufacturing of components and parts for Class I, II, and III medical devices. Commodities include electronics, molding, electro-mechanical, and mechanical industries. The role ensures design-for-manufacturing excellence (DfX) in the supply chain, qualifies new suppliers, and establishes sourcing links upon successful part qualification. The Quality Engineer also serves as a technical liaison between R&D, Supplier Quality, Commercial Operations, and suppliers, supporting inspection, validation, and documentation activities to meet regulatory standards. Key Responsibilities
Collaborate with R&D and engineering teams to evaluate new suppliers and components. Assess technical and manufacturing capabilities of prospective suppliers. Define technical requirements, tests, and documentation for sourced products. Subject matter expertise
PCBA manufacturing Electro-mechanical assembly Machining/metal forming Plastics molding Support supplier validations and qualifications, ensuring consistent product quality. Conduct measurement system analysis (MSA) at suppliers and align control plans with Receiving Inspection. Investigate and resolve supplier-related nonconformances. Manage Supplier Change Notifications, coordinating reviews of supplier and internal specification changes. Align supplier development and qualification processes with the Supplier Quality program. Maintain accuracy of the Approved Supplier List (ASL). Support supplier technical and process assessments using performance data. Assist with Supplier Corrective Action Requests (SCAR) and Supplier Notifications (SN). Review documentation to support supplier changes and work directly with suppliers to resolve quality issues. Additional Duties
Prepare and file PPAP documentation. Initiate First Article Inspection (FAI) forms and coordinate inspection activities with QA. Contribute to cross-functional projects across R&D, Operations, Production, Engineering, Clinical, and Regulatory teams. Qualifications
Education
Bachelor’s degree in Engineering (Mechanical, Electrical, Industrial preferred) required. Master’s degree in Engineering or related field preferred. Experience
5–8 years in a production or engineering environment (or 3–5 years with a Master’s). 3–5 years in medical device or other semi-regulated industries. Proven ability to coach and guide team members. Knowledge, Skills & Abilities
Strong technical knowledge in plastics/polymer molding, alloy machining and forming, and electronics/electro-mechanical assembly. Experience with product and process validation. Deep understanding of medical device manufacturing requirements. Proficiency in process capability and statistical data analysis. Working knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971. Familiarity with FDA process validation. ASQ certifications (CQA, CBA, CQE) preferred. Excellent documentation skills, attention to detail, and accuracy. Strong communication skills (written and oral) and ability to work cross-functionally. Highly organized, proactive, and collaborative team player. Ability to constructively challenge the status quo. Seniority level
Mid-Senior level Employment type
Full-time Job function
Engineering and Quality Assurance Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing Note: This posting may include location-specific salary information and related postings.
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