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.
Responsibilities and Activities
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.
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)
5+ years’ experience in a regulated manufacturing environment
Experience in new product development / processes.
CQE or equivalent course work / experience desirable.
Proficient in understanding of Med Device manufacturing processes desirable.
Familiarity with ISO 13485, QSR, GDP, GMP 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
Monday through Friday
TBD based upon candidates work ethic and performance. Minimum of 3 days in office would be required.
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; educational assistance.