Quality Engineer

Keystone Manufacturing; Oshtemo Charter Township (MI); In loco; USD 65.000 - 90.000; Tempo pieno

Vantaggi offerti da questo lavoro

Comprehensive medical coverage

Dental and vision options

Life insurance

Short term disability

Long term disability

Retirement savings plan with company 1

Paid Time Off and holidays

Descrizione del lavoro

Keystone Manufacturing, Inc. in Kalamazoo, MI seeks a Quality Engineer to develop and maintain quality standards for medical devices. The role involves root cause analysis, external complaints handling, and continuous improvement of the QMS.

The candidate should have a bachelor’s degree in engineering and at least 2 years in a regulated setting, with ISO 13485/GMP familiarity. Strong documentation and teamwork are essential for success in this fast-paced environment.

Competenze

• Bachelor’s degree in engineering or related field.
• Minimum of 2 years’ experience in a regulated manufacturing environment.
• Familiarity with ISO 13485, QSR and GMP requirements.
• Authorized to work in the US without sponsorship.
• Ability to interpret SOPs and customer specifications.
• Experience with sterile barrier packaging and clean room is a plus.

Mansioni

• Supports development of new product lines ensuring quality principles.
• Investigates external complaints and internal non-conformances; drives improvements.
• Participates in external audits (FDA, ISO) and training on QSR/ISO topics.
• Conducts internal audits and maintains Keystone QMS compliance.
• Reviews and approves SOPs aligning with regulatory requirements.
• Maintains relationships with Production, Quality, and Regulatory affairs.
• Performs product sampling and ships samples as requested.
• Assists with root cause analysis for NCRs, CARs, and complaints.

Conoscenze

calipers

rulers

micrometers

Formazione

Bachelor’s Degree in Engineering

Strumenti

Measurement equipment

Descrizione del lavoro

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).