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 Systems Manager to join our corporate Quality Systems team.

About the Opportunity:

• Successfully develop and implement a long-term strategy for Accellent’s global Quality Sytems determining what quality and compliance will look like in the future and successfully embedding a quality perspective and approach across manufacturing sites.
• The Quality Systems Manager will be responsible for the implementation and management of a dual quality system (per 21 CFR 820 and ISO 13485:2003) including the development of procedures, auditing and training for a medical device company.
• Providing the leadership to continue to grow, develop, and fine-tune the Quality System to be “Best-in-Class” with a strong focus on execution using the Quality System as a competitive advantage for Accellent.

1. Develops strategy, directs the establishment, and leads the implementation of Quality Systems improvement efforts for Accellent as part of the Corporate Quality organization. Ensure appropriate compliance and operational effectiveness in all areas of the Quality System.
2. Ensures the Quality System is understood, implemented and maintained throughout all levels of the organization.
3. Establishes and maintains an adequate organizational structure, provides adequate resources and actively participates in management reviews to ensure the Quality System is suitable and effective to satisfy regulatory requirements and the company's quality policy and objectives.
4. Directs the quality planning process to drive continuous improvements and modifies the Quality System as appropriate to ensure ongoing effectiveness and efficiency.
5. 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 mindset through leadership and training serving as a role model that drives improved compliance practices.

• Candidate must understand and be able to effectively communicate the requirements of a compliant quality system and ensure that procedures and systems are effectively implemented and maintained. Additional responsibilities will include guidance for new product development and management of complaint handling and CAPA systems.
• The successful Candidate will be a leader of the creation and championing of an atmosphere of collaboration that focuses on the overall success of the organization and helping to successfully drive the business forward.

• a minimum 8 years medical device quality system experience with a FDA/ISO compliant quality system for a company with at least 500 employees (including the implementation and management of the quality system).
• experience in a highly regulated environment such as diagnostics, medical devices, scientific and analytical equipment, and experience developing and implementing quality systems and quality assurance practices.
• a Bachelor of Science degree in a scientific discipline with an advanced degree highly preferred.
• Strong presence and confidence with the ability to communicate well with all areas of the business, as well as other constituencies and stakeholders, both external and internal.
• ISO 13485:2003 Quality System experience
• Regulatory submission and registration experience (US/EU/Canada)
•  Must be familiar and understand recognized regulatory standards such as (but not limited to) US-CFR 21 part 820, ISO 13485 – (EN) ISO 13485 and ISO 14971.
• Ability to be a superior motivator to instill discipline and focus within the organization and positively challenge their team to exceed performance standards. 
• Extensive Audit experience
• Extensive background writing and implementing SOP's
• Passionate, high-energy leader with a forward thinking, strategic perspective.
• Demonstrated ability to be a strong problem solver and decision maker with the courage and conviction to follow through on decisions and the presentation skills and credibility to win support and align the organization; possess a high level of intellectual curiosity and analytic skills.
• Entrepreneurial attitude and mindset combined with the appropriate process orientation and focus.  Self-motivated with a sense of urgency and accountability.  Energetic and hardworking.
• Adaptable and resilient with the ability to successfully deal with and sort through ambiguity, as well as, embrace change.  Able to juggle multiple high priority tasks.

• Smart, well-rounded, energetic, and confident leader.
• A team player that can work well with the other executives to achieve the goals and objectives of the Company. 
• Passionate about the success and growth of the Company, business, and the team.
• Innovative, practical, technically astute, and capable of healthy dialogue in the exchange of ideas in reaching conclusions.
• Demonstrated ability to lead organizations and blend together diverse skill sets.  Dedicated to results through the achievement of their people and organization.
• A willing and innate team player, with the capacity and aptitude to serve as a coach and mentor to motivate, inspire, grow, and lead in a cross-functional matrix organization.  Ability to be passionate and focused, but still have fun and deliver results.  
• Able to demonstrate impeccable ethics and integrity that are required to build both internal and external credibility.