Director Of Quality

Micron Solutions is a multifaceted contract manufacturing organization specializing in thermoplastic injection molding, precision machining and finishing, and silver-plated medical sensors for disposable electrodes. We work with clients of all sizes to provide manufacturing solutions and assembly services to help our customers meet their goals. Our 120,000 square foot Fitchburg, MA manufacturing facility is capable of serving customers’ projects from concept to commercialization.

Job Purpose

Responsible for setting the vision for the company’s quality organization and developing strategies to drive the company towards achieving that vision. Ensures the company’s Quality System meets all applicable regulatory standards and regulations. Develops, establishes, maintains, and improves Quality Assurance and Quality Control procedures, instructions, and controls for compliance in key Quality areas: Management Review, CAPA, Training, Internal Audits, Control of Non-Conforming Product, Supplier Management, Risk Management, Validation, and Process Controls. Serves as site Quality Representative for FDA, ISO, and Customer audits. Ensures prompt follow-up on customer audits, Complaints, and Supplier Corrective Action Requests.

Responsibilities

The Quality Director:

• Along with all other members of the management team, has direct responsibility to propose, support, and enhance safety initiatives throughout the organization
• Must have an expert understanding of quality management systems as related to FDA’s 21 CFR 820, ISO 13485, and ISO 14971
• Manages quality team personnel in the following key areas:

• Oversees Internal Audit program.
• Material Review Board (MRB) for non-conforming products working with Engineering, Supply Chain, Manufacturing for the timely disposition of non-conforming products along with managing Supplier Corrective Actions (SCARs) and Internal Corrective Actions (ICAs).
• Oversees the management of the employee Quality System Training program.
• Ensures appropriate training of all personnel for quality awareness and GDP
• Supports supplier management program
• Oversees the administration of the document control system
• Plans, coordinates, implements and directs 21 CFR 820 and ISO 13485 compliant quality program designed to assure consistent production of components to requirements at all levels of the organization
• Assures that appropriate procedures and instructions are in place and effective in controlling materials, facilities, and products in a manner which ensures compliance with customer requirements and the requirements of the Quality Management System (QMS)
• Ensures overall compliance to the QMS by designing and maintaining a system that is organized in a manner that provides a level of responsiveness that is timely and effective
• Formulates appropriate quality objectives for the organization in partnership with senior management
• Ensures that appropriate monitoring programs are in place to provide an assessment towards established goals/objectives, including but not limited to, the goals of improving product/process reliability and minimization of product costs
• Reports the status of the QMS to senior management via Management Review and Key Performance Indicator (KPI) meetings
• Organizes, analyzes, and ensures the appropriateness and accuracy of data for Management Review Meetings and KPI Meetings
• Develops, reviews, and approves Quality System all levels of quality systems documentation (procedures, forms, Quality Plans, etc.) and ensures alignment with processes and practices
• Defines and tracks quality objectives, data and metrics with the goal of continuous improvement.
• Serves as Management Representative hosting all external Registrar/ FDA/ Customer audits
• Oversees company response to external audits, complaints, and Customer SCARs
• Manages Quality Control and Quality Assurance/Engineering function
• Directly manages Complaints Systems and oversees management of the CAPA system, including initiation and support of the root cause investigation, closure, and verification of effectiveness of the action taken.
• Identifies opportunities for the use of Kaizen events/activities and facilitates such events to ensure timely thorough response to customer issues and in support of Continual Improvement activities.
• Drives risk management strategy for quality system and core internal processes
• Develops or provides input for employee QA system requirements and compliance expectation training
• Works collaboratively with Operations, Engineering and Manufacturing to support new product introductions
• Drives and supports validations as required (process, product, and software)
• Reviews, assesses the risk of, and approves Document Change Requests/Orders, Engineering Change Requests/Orders, MRB Dispositions, and planned/executed actions related to complaints, CAPAs, and Nonconforming Product

Job Qualifications

• Competent with Microsoft Office Program
• Knowledgeable (SME) of ISO 13485 and ISO 14971
• General understanding of Statistical Process Control
• BS/BA Degree, preferably in an engineering discipline
• 7-10 years of experience in quality with a minimum of 5 years in a leadership role

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Tuition reimbursement
• Vision insurance

Schedule:

• Day shift
• Monday to Friday

Ability to commute/relocate:

• Fitchburg, MA 01420: Reliably commute or planning to relocate before starting work (Preferred)

Experience:

• ISO 9001: 1 year (Preferred)

Work Location:

• One location

Work Remotely:

• No

Work Location: One location