Manager Quality Assurance Job Listing at Accellent Inc. in USA (Job ID accellent-2861)

Health Products & Services

Manager Quality Assurance

Tracking Code
7543
Job Description

Accellent, Inc. is a fully integrated provider of design, supply chain management and strategic sourcing services to the Medical Device industry. Accellentwww.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. 

The Quality Manager will be expected to provide leadership and management for QA activity in a manufacturing facility; interact with customers and provide leadership support for Engineering, Quality Systems and Process engineering.  

 

This position is based at our Brimfield, MA manufacturing site.

 

Requirements:

* Work collaboratively with Engineering, Operations, and other functional groups to successfully and seamlessly deliver to customers an integrated set of services and products.
* Work collaboratively with site management team to successfully and seamlessly deliver to customers an integrated set of services and products.
* Be a resource and mentor to other members of the management team, with a responsibility to develop people and support corporate goals of employee engagement.
* Talent acquisition and development.  Recommends and executes personnel actions including promotions, performance reviews and any disciplinary measures. 
* Responsible for business improvement programs and initiatives such as Complaint reduction, Quality System improvements (CAPA, NCR, Training, etc), cost improvement programs through Lean Manufacturing techniques and drive successful business excellence programs for manufacturing to support business opportunities.
* Ensures output, timeliness, quality and Cost to standards consistent with customer requirements and company strategy.
* Support strategies to help drive improvements in operational capability required to support corporate growth and strategies.
* Reduce manufacturing operations costs through innovation and productivity gains.
* Create a continuous improvement culture that strives to satisfy customer requirements for fill-rates and zero defects.
* Complies with all work rules including those pertaining to safety, health, quality and Accellent Quality Management System.
* Develop and drive implementation of the quality system architecture, staffing, and associated processes to ensure adequate checks and balances exist as well as establishing the appropriate independence of the quality function. 
* Leads management reviews, to ensure the quality system is suitable and effective to satisfy regulatory requirements and the company's quality policy and objectives and other applicable procedures and practices at all levels of the organization.  
* Develops and drives a work culture fostering a highly ethical environment grounded in credibility and trust and fully committed to patient safety, compliance, quality and customer focus.
* Builds a strong quality team through staffing, leadership and training serving as a role model that drives improved compliance practices.
* Performs other duties as necessary. 
 

 

Required Experience

Requirements:

* Bachelors degree in engineering or technical equivalent degree
* 10 years experience in manufacturing, preferably medical devices, including at least three years leadership responsibilities with increasing responsibility in quality assurance and associated fields.
* Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office and Statistical packages.
* 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.
* Be familiar and understand recognized regulatory standards such as ( where applicable)
* US – CFR 21 part  820 (FDA QSR, GMP)
* ISO 13485 - (EN) ISO 13485
* Medical Device Directive (MDD) 93/42/EEC
* Active Implantable Medical Device Directive (AIMD) 90/385/EEC
* In Vitro Diagnostic Medical Device Directive (IVDD) 98/79/EC
* ISO 13485under Canadian Medical Device Conformity Assessment System (CMDCAS)ISO 14971, AS 9100, ISO 9001
* Able to be technically comprehensive and knowledgeable including standard business ERP system principles, as well as technical aspects such as statistics, documentation, SPC, Geometric Tolerencing and mechanical drawings and associated software packages. 
* Familiar with Six Sigma and/or a history of lean manufacturing, Kaizen and 5S, etc.  Six-Sigma certified or willing to obtain certification preferred.
* Must possess excellent verbal & written communication skills, as well as presentation, organizational and management skills.
* History of recruiting and retaining exceptional talent.
* Prior experience with environmental controls, biocompatibility and associated control systems preferred
* Knowledge of machining, metals processing and fabrication, and product assembly in the medical device industry.
* Working knowledge of capacity planning and logistics management.
* Demonstrated leadership and team building skills.
* Ability to interface with customers, problem solve and drive solutions to meet customer requirements.
* Hands on leader with demonstrated experience at successful high performance team building as a coach and mentor.
* Strong communicator with internal and external customers in all areas of the business: written and verbal (one-on-one and group).
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 atwww.accellent.com 

 

 

Job Location
Brimfield, Massachusetts, United States
Position Type
Full-Time/Regular