You May Not Recognize Our Name, but You Know Our Products

You may not recognize our name, but you know our products.

ASO has become the market leader in producing high-quality consumer wound and health care products which are now the preferred choice for consumers in the USA and abroad.

ASO products are primarily sold under the brand name of mass merchandisers, food & grocery retailers, drug store chains, as well as distributors in professional medical markets. ASO has partnered with these retailers to provide high quality products with innovative brand strategies which build store brand value, increase returns, and enhance market share in the categories of products we provide.

Our success is directly attributable to ASO’s talented employees who innovate, create and support the highest quality products within our marketplace at the best possible price and value for the consumer.

We are currently seeking to hire a Quality Assurance Manager. The QA Manager is responsible for leading, planning and coordinating ASO’s quality assurance programs ensuring adherence to established quality system requirements and standards, including cGMP, FDA, ISO, CMDCAS and MDD requirements.

Functional Responsibilities:

Tactical Responsibilities:

·  Responsible for site quality management including: inspection activities, corrective and preventive actions, document control, sterility assurance, complaint process and handling of internal audits and non-conformances.

·  Responsible for implementation of corporate policies and procedures to maintain the effectiveness of the quality management system at the assigned plant locations.

·  Develops and analyzes statistical data and product specifications to determine present standards and established acceptance quality level expectancy of finished product are being met.

·  Develops and implements continuous improvement programs for quality inspection techniques and inspection, testing and measurement tools to monitor the effectiveness of quality inspection processes from receiving inspection to finished product inspection and final release.

·  Formulates and maintains site quality objectives and coordinates objectives with production procedures in cooperation with other managers to maximize product quality and minimize costs.

·  Oversees inspection and testing for incoming and in-process materials and products in accordance with established and approved test plans.

·  Plans, promotes and organizes training activities related to product quality acceptance criteria, FDA, MDD, CMDCAS and other quality and regulatory requirements.

·  Actively monitors company policies, procedures and actual practices to ensure compliance with applicable regulations and requirements.

·  Analyzes and resolves work problems, or assist employees in solving work problems.

·  Investigates customer complaints and maintains complaint records in accordance with established procedures

·  Prepares, edits and maintains control of site quality documentation required to meet quality system requirements, such as site specific SOPs, Device Master Records, Quality Plans and Bills of Material (BOMs).

·  Oversees document control activities.

·  Other duties as assigned.

Leadership and Management Responsibilities:

Recruitment and Retention:

·  Interview and hire quality assurance departmental staff.

·  Communicate departmental staffing needs and criteria to Human Resources and executive management.

·  Coach team members in the interviewing / hiring process.

·  Monitor team member turnover; identify key factors that can be improved; make improvements.

Employee Development:

·  Identify strengths and development needs on an ongoing basis.

·  Create and / or validate training curriculum in area of responsibility.

·  Coach and mentor team members to deliver excellence to every internal and external customer.

·  Create and manage succession plans for Supervisors / Floor Support positions.

·  Utilize position-specific training checklists; ensuring employees are properly trained, knowledgeable in their position, and familiar with respective job requirements.

Performance Management:

·  Establish clear measurable departmental goals and objectives that complement overall management goals and objectives (e.g., QA metrics, results against project timelines, training documentation, attendance records, knowledge of QA roles and responsibilities, personal development goals).

·  Solicit ongoing feedback from coworkers and superiors. Provide ongoing coaching and counseling to team members based on the feedback

·  Express pride in staff and encourage them to feel good about their accomplishments.

·  Perform staff evaluations professionally and on time.

·  Ensure recognition and rewards are managed fairly and consistently.

·  Promote departmental continuous improvement in key operational metrics and the achievement of the organizational goals.

·  Coordinate activities of quality committees to meet established timelines and expectations (e.g. CAPA committee, Internal Audit teams, MRB committee, etc.)

Communication:

·  Provide communication forum for the exchange of ideas and information with the department.

·  Communicate verbal and written ideas clearly and encourage open discussion and feedback.

·  Assess communication style and operational vocabulary used within the organization and adapt own communication style accordingly.

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education:

Bachelors degree in science with an emphasis in quality management required, masters degree preferred. Six Sigma or Lean Manufacturing experience a plus.

Experience:

Minimum of five years of related quality assurance/quality control supervisory experience in a manufacturing environment. Medical device experience preferred.

Skills & Abilities:

Must possess a sound understanding and working knowledge of FDA, ISO, cGMP, CMDCAS and MDD regulations and be able to effectively communicate and implement processes and systems to comply with these standards at plant location(s). Must be able to create and maintain a professional and pleasant/positive working environment that encourages an open exchange of ideas and fosters a team approach to work through challenges and opportunities for improvement. Must be able to develop work and project plans and be able to prioritize, plan and execute work activities consistent with business demands. Must be aligned with operations and other departments on daily priorities and work flow needs. Must be able to complete projects on time in budget and be strong at holding people accountable for responsibilities, both internal and external to his/her area. Comprehension of sterility fundamentals, including microbiology, desired. Must be computer literate and proficient in the use of MS Office and Outlook. Prior use of MRP systems highly preferred. Must be able to write business correspondence and technical documents and effectively present the information responding to questions from groups of managers, clients, customers, and the general public. Use fact-based data utilizing mathematical concepts including probability and statistical inference to make conclusions and drive decisions. Must be a problem solver, responding to a variety of concrete variables in situations where only limited standardization exists. Must be detail-oriented, possess sound communication skills, written and verbal, and able to travel and work a flexible schedule as required. Visual acuity or corrective vision required for this position including close vision, distance vision, and color vision. Possesses initiative, common sense and analytical/problem-solving characteristics. Able to speak, read, and write in English.

As a growing global company, ASO is committed to cultivating an entrepreneurial, respectful and engaging work environment that inspires a diverse team of employees to thrive professionally and make a direct contribution to the customers we serve. At ASO, we believe our employees are what differentiates us as a company - Our employees make the difference!