POSITION SUMMARY

The primary responsibility of this role is to serve as a lead representative of assigned product lines for new product development, day-to-day manufacturing support, non-conformance, and acts as the independent review function. The Quality Engineer supports additional processes such as Supplier Quality, Internal Audit, Corrective and Preventive Action Procedure for Good Manufacturing Practice (CAPA), etc., in order to effect operational efficiency and economy, the Quality Engineer ensures continuous production of parts consistent with established standards, and to meet the customer’s desired results. This position operates under minimal guidance from management or senior staff. The Quality Engineer ensures ProMed’s brand, philosophy, systems, policies, and procedures are properly implemented and observed.

ESSENTIAL DUTIES & RESPONSIBILITIES

Position duties and responsibilities include, but are not limited to the following:

• Adheres to 21CFR 820, 210, 211 and ISO 13485.
• Develops and/or revises standard operations and working practices;
• Develops and conducts training sessions related to revised practices; and
• Reviews documentation and records to ensure compliance;
• Be the voice of quality for daily manufacturing in assigned departments by partnering with Operations and Engineering and providing guidance on issues in line with external standards, internal standards, and best practices;
• Develops and maintains strong relationships with production leads and production personnel;
• Leads engineering investigations when production issues arise;
• Facilitates development and implementation of production processes and controls (i.e. qualification, process capability, sampling plans, validation, etc.);
• Analyzes statistical data and product specifications to evaluate current standards and achieve targeted quality and repeatability;
• Assists with investigation of product non-conformance/complaints, root cause analysis, monitoring/trending of process and product, escalation of identified issues, and implements corrective action as it pertains to customer complaints and internal non-conformance;
• Plans, drafts, and routes change requests as necessary;
• Identifies and/or resolves dimensional characterization methodology and inspection criteria;
• Evaluates and recommends process improvements;
• Qualifies/validates processes and/or equipment to meet customer and ProMed’s objectives;
• Identifies customer needs and new manufacturing capabilities to enable future growth;
• Creates and reviews Process Failure Mode and Effects Analysis (pFMEA)s for new projects and existing production lines;
• Identifies actions to reduce or eliminate the chance of failure occurrence;
• Identifies process variables that, if controlled, can reduce the occurrence or improve the detection of failure conditions;
• Executes data analysis and generates reports for new product development team and production projects;
• Reviews prints and provides recommendations based on Design for Manufacturing principles;
• Manages the execution and reports generation for Gage R&Rs (gage repeatability and reproducibility);
• Manages and executes component qualification, validation and equipment qualification;
• Supports new product development, as needed;
• Meets expectations of regular, reliable attendance;
• Any other duties and tasks as deemed necessary and appropriate.

QUALIFICATION, EDUCATION & EXPERIENCE

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• Engineering/Science degree with drug/medical device-related background and a minimum of 3 years’ experience in the field
• Experience in the Medical/Cleanroom industry
• Knowledge of medical device regulation (21 CFR 4, 210, 211, 820), QMS Standard ISO 13485, risk management (ISO 14971)
• Must have Intermediate knowledge of Microsoft Office products to include, Word, Excel, PowerPoint, Outlook, and Project
• Commitment to continuous improvement company-wide
• Excellent communication and interpersonal skills both written and verbal; professional, courteous and friendly personality; clearly conveys ideas and information and receives information effectively
• Excellent organizational, problem-solving and time-sensitive skills
• Ability to create positive working relationships with a diverse group of people including gender, ethnicity, age, and cultural and skill level differences
• Ability to establish priorities and meet deadlines

Preferred:

• Professional certification (i.e. ASQ, Six Sigma, etc.)
• Proficiency in statistical, quality and continuous improvement methods and tools
• Knowledge of Coordinate Measuring Machine (CMM) dimensional measuring equipment, pin gages, and calipers, as well as other equipment as required
• Knowledge of Statistical Process Control (SPC), Minitab, SQC pack, design of Methodology and blueprint reading
• Problem-solving and critical thinking skills
• Strong interpersonal, written, and verbal communication skills
• Clearly conveys ideas and receives information effectively
• Self-starter with a proven ability to successfully work with minimal supervision
• Professional, courteous, and friendly personality
• Working knowledge of English (verbal and written)