Quality Engineer

Keystone Manufacturing Llc; Kalamazoo (MI); Sur place; USD 70 000 - 90 000; Plein temps

Avantages offerts par ce poste

Medical, dental, vision

Life insurance

Disability insurance

Retirement plan with company match

Paid time off and holidays

Résumé du poste

Keystone Manufacturing Llc in Kalamazoo, MI is seeking a Quality Engineer to develop, maintain and improve quality standards for medical device manufacturing. The role involves root cause analysis, investigations into external complaints and internal non-conformances, and driving continuous QMS improvements.

Candidates should have a Bachelor’s in Engineering and at least two years in a regulated environment, with ISO 13485/QSR/GMP experience and proficiency in measurement tools.

Qualifications

• Bachelor's in Engineering required.
• Minimum 2 years in a regulated manufacturing environment.
• Experience with ISO 13485, QSR, GMP.
• Familiarity with measurement equipment (calipers, rulers, micrometers).
• Authorized to work in the US without sponsorship.

Responsabilités

• Supports development of new product lines with quality considerations.
• Supports operations of critical quality issues to ensure effective manufacture of medical devices.
• Identify and communicate system improvements to meet target timeframes from compliance and business perspectives.
• Participates in external compliance audits – FDA, ISO, etc.
• Conduct and/or support training on QSR and ISO topics.
• Contributes to root cause analysis for NCRs, complaints and CARs.
• Conducts internal audits per Keystone Manufacturing QMS requirements.
• Work with production to resolve customer/product issues as needed.
• Reviews and approves SOPs ensuring alignment with requirements.
• In-house expert for EO sterilization and label creation.
• Maintain relationships with Production, Quality, regulatory affairs.
• Product assembly and production processing in times of need.
• Follow quality systems procedures as required.
• Prepare and ship samples to customers as requested by sales.

Connaissances

Quality engineering

Regulated manufacturing

Root cause analysis

Documentation

Formation

Bachelor's Degree in Engineering

Outils

Calipers

Micrometers

Rulers

Inspection equipment

Description du poste

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Quality Engineer

Quality Full Time Professional Kalamazoo, MI, US

2 days ago Requisition ID: 1109

Position: Quality Engineer

Overview

We are looking for a talented individual to join our dynamic Keystone Manufacturing team located in Kalamazoo, MI. The Quality Engineer is a motivated, self-starter who is responsible for the development, maintenance and modification of quality standards for products and processes to ensure the effective manufacture of medical devices. This position will be responsible for investigations and root cause analysis into external Complaints and internal Non-conformances and driving continuous improvements of the Keystone Manufacturing QMS.

The successful candidate must be capable of working with minimal supervision, have a “can do” attitude, possess creative problem-solving skills and be willing to do “whatever it takes” to complete assigned tasks efficiently and effectively. This team member should have excellent interpersonal skills, great attention to detail and be highly organized with the ability to multi task with minimum interruption to work progress.

Job Duties

• Supports the development of new product lines, assuring the quality aspects are accounted for and attainable
• Supports operations of critical quality issues to ensure the effective manufacture of medical devices
• Identify and communicate system improvements to allow for efficient and effective practices to meet target timeframes from both a compliance and business perspective
• Participates in external compliance audits – FDA, ISO, etc.
• Conduct and/or support training on QSR and ISO topics.
• Contributes to the root cause analysis for NCR, Complaints and CARs
• Conducts internal audits per Keystone Manufacturing QMS requirements
• Work with production to solve customer/product issues as necessary
• Reviews and approves SOPs ensuring alignment with Corporate, Site and Regulatory requirements
• In-house expert for EO sterilization and label creation
• Establish and maintain effective working relationships with Production and Warehouse/Distribution staff, corporate and site Quality, study management and regulatory affairs
• Product assembly and production processing in times of need
• Responsible for following quality systems procedures as required
• Prepare and ship product samples to customers as requested by sales
• Perform other duties as assigned

Requirements and Qualifications

• Bachelor’s Degree in Engineering
• Minimum of 2 years’ experience in a regulated manufacturing environment.
• Experience and working knowledge of current ISO 13485 standards, QSR, GD, GMP required.
• Familiarity with measurement equipment: calipers, rulers, micrometers, etc.
• Familiarity with ISO Standards and GMP preferred.
• Authorized to work in the US without sponsorship.
• Must be able to routinely make decisions that immediately impact operations.
• Must be able to understand and execute tasks per Standard Operating Procedures and Customer Specifications.
• Must have the ability to operate hand tools, inspection equipment, and common office equipment.
• Must have the ability to operate in a fast-paced environment, sometimes requiring extended work hours, including evenings and weekends as necessary, to ensure minimal interruption to production.
• Must have excellent interpersonal communications skills to ensure core corporate values are demonstrated and promoted to all coworkers.
• Must have excellent documentation and organizational skills.
• Experience with sterile barrier packaging is a plus.
• Experience working in a clean room is a plus.
• Experience with single use disposable medical devices is a plus.
• Experience with seal integrity and seal strength testing is a plus.
• References must be provided upon request.
• Basic computer skills (word processing, spreadsheets, database)
• CQE or equivalent course work / experience desirable.
• Proficient in understanding of Med Device manufacturing processes desirable.
• Excellent full-time benefits including comprehensive medical coverage, dental and vision options.
• Company paid life insurance, short term disability and long-term disability insurance.
• Retirement savings plan with company match.
• Paid Time Off and holidays.

Schedule

Monday through Friday (weekends and/or holidays depending on customer demand).