Job Type: Full time
Location: Kalamazoo, MI
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 as well as supporting the validation of new and existing sterilization modalities to ensure the effective manufacture of single-use medical products. 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 and other sterilization modalities and label creation
- Provide support for controlled environment and sterilization nonconformance or excursion events including root cause investigation
- Compile, interpret and act on validation reports for clean room qualification and sterilization validations
- Establish and maintain effective working relationships with Production and Warehouse/Distribution staff, corporate and site Quality, study management and regulatory affairs
- Provide support for controlled environment and sterilization Nonconformance or excursion events including root cause investigation
- Compile validation reports for clean room qualification and sterilization validations
- 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
- Some advanced studies in sterilization and work towards a certificate program ideal
- Experience with single use disposable product
- 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)
- Experience in new product development / processes desirable
- CQE or equivalent course work / experience desirable
- Proficient in understanding of Med Device manufacturing processes desirable
Benefits
- 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)
