Quality Manager

Accellent, Inc. is a fully integrated provider of design, supply chain management and strategic sourcing services to the Medical Device industry. Accellent www.accellent.com, a recognized market leader, is a fast-growing outsource manufacturing and design solution company specializing in high growth areas such as Cardiology, Endoscopy and Orthopaedics. The top Medical Device companies partner with Accellent to provide innovation, advanced technology, speed to market, low cost labor and strategic sourcing.  We’re looking for team players with a can-do attitude to share in our vision and corporate values. Accellent offers competitive salaries; a comprehensive benefits package, and a stimulating work environment.  Currently, we are searching for a Quality Manager to join our Chicagoland (Wheeling), IL facility. About the Opportunity: Position Scope/Summary The incumbent will be responsible to provide effective management of the Quality systems departments. Interact as a peer with all operations managers. Interact with customers and provide support for the engineering department. Represent Accellent in a professional and exemplary manner before our suppliers, employees and community at large. Key Result Accountabilities 

· Act as champion for Quality Systems Best Practices.

· Manage all Quality related departments

· Management Representative for the Brimfield Facility.

· Support implementation and continuous improvement of processes through SPC and process control.

· Provide sponsorship and act as change facilitator for SPC, FMEA, DOE and process validation systems.

· Provide oversight and Project Management support as needed for product transfers.

· Oversee IQ, OQ and PQ protocols to ensure compliance with the Quality System.

· Manage the Quality Systems Group to provide Document Control, Incoming Inspection, Product Release, Complaint Analysis, Corrective and Preventative Action Reporting and Quality Control training to facility

· Coordinate Supplier, Internal and Customer Audits.

· Ensure that these actions are performed in compliance with FDA 21 CFR 820, ISO 13485:2003, ISO 14971, and other appropriate Federal, International Standards, local employment laws, and company policy.

· Comply with all work rules including those pertaining to safety, health, quality, QSR’s and the Quality System Management System.

· Performs other duties as necessary. Environmental Working Conditions  

Employee must comply with and enforce all safety policies and safe work procedures established by the company. Employee will be required to deliver safety training, serve on the facility safety committee and perform hazard analysis and resolution. Job tasks may also involve:

· Using and providing employees with personal protective equipment such as safety glasses, goggles, gloves, and other equipment as established in company policies and safe work procedures.

· Training employees to work safely with cutting & machining fluids, solvents, lubricants and other hazardous chemicals.

· Establishing, training employees and enforcing safe work procedures for all operations under their control. 

· Performing accident investigation and appropriate follow up.

Employee will be expected to serve as an example for all employees with respect to safety.



Qualifications  

· Bachelor of Science Degree, preferably in an engineering discipline, plus 5 years experience in Quality, preferably medical devices, with increasing responsibility, or minimum of 10 years experience in a manufacturing /QA environment.

· Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office and Statistical packages.

· Must be familiar with MRP, SPC, Geometric Dimensioning & Tolerancing and mechanical drawings.

· Must possess excellent verbal communication, organizational and management skills.

· Experience in Medical Implant and Instrumentation and medical device assembly a plus.

· Complete all job specific required training.

· Perform duties to achieve overall facility metrics.

· Comply with all safety regulations, wears appropriate safety equipment as required in each area of the facility.    It is impossible to list every requirement for, or responsibility of, any position. Similarly we cannot identify all the skills a position may require since job responsibilities and the Company’s needs may change over time. Therefore, the above job description is not comprehensive or exhaustive. The Company reserves the right to adjust, add to or eliminate any aspect of the above description. The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.

Due to the expected number of responses, only those most qualified will be contacted.  No recruiters please; all unsolicited third-party submissions will be rejected.

 



 

 



Accellent is an Equal Opportunity/Affirmative Action employer and we value diversity in our workforce. As such we provide equal opportunity for all applicants without regard to race, religion, gender, national origin, age, marital status, veteran status, or disability.  To learn more about Accellent and our career opportunities, please visit us at

www.accellent.com Job Code : 2720 # of Openings : 1 Skills : Quality Assurance -> Validation, SPC, Risk Analysis, Protocol writing, Failure/root cause, Design Controls Travel Required : 0-10% Shift/Hours : First Shift (Day)