WHAT WE DO AT COMPONENT SUPPLY:
Component Supply is an ISO-certified company serving the medical device, aerospace, and laboratory sciences industries by producing quality components primarily from small diameter metal and plastic tubing and wire. The Quality Manager reports to the Vice President of Sales and Marketing while fulfilling the responsibilities listed below.
AS A COMPONENT SUPPLY TEAM MEMBER, YOU WILL:
· Work in an energetic team environment.
· Be eligible for paid vacation, holidays, medical insurance, and an employer-match retirement program.
· Receive comprehensive training for the work you are expected to perform.
RESPONSIBILITIES
· Own and maintain the company's Quality Management System (QMS) in accordance with ISO 13485 and other applicable regulatory and customer requirements.
· Manage all controlled quality documentation, including procedures, work instructions, forms, records, and document revisions.
· Ensure compliance with customer, regulatory, and industry requirements, including but not limited to RoHS, REACH, DFARS, Conflict Minerals, Animal-Derived Substances, and other customer-specific declarations.
· Develop, maintain, and issue Certificates or Statements of Compliance and support customer documentation requests.
· Manage supplier quality activities including supplier qualification, evaluations, quality agreements, supplier surveys, performance monitoring, and approved supplier records.
· Oversee incoming inspection activities for purchased materials and final inspection processes for fabricated products to ensure compliance with customer specifications.
· Manage the identification, segregation, disposition, and documentation of nonconforming materials and products.
· Investigate product quality issues, including incoming material nonconformances, internal nonconformances, customer complaints, supplier quality issues, and corrective actions.
· Lead the Corrective and Preventive Action (CAPA) process, ensuring root cause investigations, implementation of corrective actions, verification of effectiveness, and proper documentation.
· Coordinate cross-functional investigations involving Operations, Sales, Purchasing, Engineering, suppliers, and customers to resolve quality issues.
· Partner with Sales, Engineering, and Operations during contract review to evaluate customer quality requirements and determine the company's ability to meet customer specifications.
· Manage approved supplier qualification and ongoing supplier performance.
· Plan, coordinate, and lead internal audits, customer audits, and third-party certification audits while ensuring timely resolution of audit findings.
· Develop and deliver quality-related training programs and maintain competency records for personnel performing quality-related activities.
· Train, mentor, and coordinate internal auditors to ensure effective execution of the internal audit program.
· Monitor quality system performance through key performance indicators (KPIs) and prepare management review data, reports, and recommendations.
· Support continuous improvement initiatives that improve product quality, process capability, customer satisfaction, and operational efficiency.
· Serve as the primary quality representative for customers, suppliers, and regulatory agencies regarding quality system matters.
· Ensure quality and traceability requirements are maintained throughout both distribution and fabrication operations, including lot traceability, inspection records, certifications, and customer documentation.
REQUIREMENTS:
· Bachelor’s degree or 5 years of management experience.
· Internal Auditing Training Certificate
· Professionalism in dress and communication.
· Strong attention to detail.
· Problem-solving skills.
· Ability to multitask and effectively prioritize tasks.
· Time management skills.
· Excellent written and oral communication skills.
COMPENSATION:
· DOE
· IRA match up to 3% upon one year of employment.
· Health Insurance options; 50% employer contribution.
· Company PTO Schedule.
Job Type: Full-time
Pay: From $50,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Application Question(s):
- Are you currently working?
Education:
Experience:
- Management: 5 years (Required)
License/Certification:
- Driver's License (Required)
Work Location: In person
