Manager, Quality and Regulatory

Vention Medical  •  Minneapolis, MN

11 - 15 years experience  •  Biotech/Pharma

$120K - $160K
Posted on 10/25/17
Vention Medical
Minneapolis, MN
11 - 15 years experience
Biotech/Pharma
$120K - $160K
Posted on 10/25/17

POSITION SUMMARY:

A high-performing individual to provide hands-on leadership to the Product Design & Development (D&D) team, and to be a key individual in the areas of Quality Engineering. Medical device development and manufacture experience is essential. Injection molding experience is also a strong plus. The individual will possess a broad range of medical device quality skills and experience, a record of leading and participating with teams from product concept through validation and into manufacturing, as well as in-depth knowledge in several clinical and product areas. This individual will also play a key role in mentoring less experienced employees, and must be self-motivated and excited by the prospect of working in a dynamic, entrepreneurial environment. 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

·     Team Player/Coach 

o     Committed

o     Collaborative

o     Communicative

o     Enthusiastic

o     Problem Solver

·     Plays a major role in meeting or exceeding customer project objectives.

·     Able to lead projects, directly contribute and/or provide guidance to others to establish clinical, pilot production and scale-up plans in New Product Introduction programs.

·     Ensures that all direct reports are efficiently utilized and billable at target levels.

·     Identifies, and supports the pursuit of, new business opportunities. Works collaboratively with Vention sales personnel to close sales.

·     Participates in the organization and execution of interdepartmental activities to ensure the completion of projects on schedule and within budget constraints.

·     Interacts with customer and supplier companies in a professional manner; proactively communicates with them to ensure an ongoing two-way exchange of information.

·     Intervenes and contributes to successful resolution of technical issues when they arise.

·     When required, manages large or strategic Product Development projects. Prepares project plans that define phases, tasks, durations, resource assignments, and costs. Proactively communicates assignments to responsible individuals, ensures that tasks are completed within the planned time and reports project status to the project’s client company.

·     Writes and/or reviews proposals for prospective projects. Ensures all proposals are professionally done and contain accurate technical content, costs and time estimates.

·     Ensures that all work satisfies the requirements of the company's Quality Manual, with particular emphasis on Design Control.

·     Experience with Injection Molding preferred.

·     Experience in Quality Project Leadership preferred.

·     Responsible for assuring product quality, safety and effectiveness, and conduct of failure investigations of customer complaints, as required.

·     Responsible for timely Corrective and Preventative Actions (CAPA), change control and notification, internal and vendor audits, product release, document control, design control process and design history files (DHF), device master records, etc.

·     Manage the resources of the Quality Department to ensure staff are selected and sufficiently trained to meet current and future work requirements. Work with staff in administering the performance management system to ensure development needs are met and feedback is provided on a regular basis. Ensure the proper application of Human Resource policies through recommendation and approval of Human Resource actions such as salary administration, disciplinary action, and paid time off.

REQUIRED COMPETENCIES

Demonstrate the ability to get things done individually and through others by delegating, influencing and monitoring in order to bring work to completion. Inspire confidence, respect and enthusiasm.

Customer Focus

Provide professional, reliable and prompt service to internal and external customers. Work in partnership with others to meet and exceed customer expectations. Interpret customers’ needs and take appropriate action. Follow through on customers’ inquiries in a professional and timely manner. Identify and communicate the most prudent path forward for the customer given the business goals of the customer.

Management of Resources

Be well organized and use time efficiently. Be familiar with all reference materials and locate needed information as necessary. Take initiative for self-development. Prioritize tasks effectively. Demonstrate initiative and innovation in the use of available resources.

Communication Skills

Assure that all verbal and written communications are concise, technically accurate, timely, and professional. Demonstrate strong verbal presentation and negotiation skills. Make presentations in a positive and professional manner. Express ideas, recommendations and solutions clearly, logically and concisely in both written and verbal communications. Demonstrate tact and diplomacy in communications. Demonstrate active listening skills and ability to resolve discrepancies with customers.

Team Building

Resolve conflict with others in an effective, positive, and mature manner. Work well with others to meet goals.

Adaptability

Remain flexible and resilient. Respond positively to changing priorities. Accept new techniques and procedures quickly and employ them into daily job functions. Effectively handle special assignments outside of daily functions.

Business & Systems Knowledge 

Demonstrate knowledge of raw materials, production processes, quality control and appropriate use of equipment. Utilize systems to complete assigned tasks. Identify opportunities to change processes or use technology to improve efficiency.

SUPERVISORY RESPONSIBILITY:

Manages quality assurance, quality control and regulatory staff.

WORKING CONDITIONS/PHYSICAL DEMANDS:

Must be able to move throughout office and laboratory space using a complete variety of office equipment and laboratory machinery and tools. Must be able to stand for extended periods of time. Must tolerate exposure to chemicals found in the Vention laboratory environment and demonstrate knowledge of safety techniques required when there is a possibility of contamination by bloodborne pathogens.

REQUIREDEDUCATION, EXPERIENCE, SKILLS AND KNOWLEDGE:

·     Degree in Engineering

·     Experience in medical device is essential, minimum ten (10) years, quality leadership desirable

·     Experience in Injection Molding preferred.

·     Excellent communication skills with ability to interface at all levels.

·     Ability to recruit and retain high caliber staff, developer of people through professional and personal mentoring.

·     Required proficiency in the management of Quality; team player focus.

·     Excellent computer skills.

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