Quality Engineering Manager

70,000.00 - 75,000.00 USD /yearsalary commensurate with experience Status: Full Time, Employee Job Category: Quality Assurance/Safety Relevant Work Experience: 7+ to 10 Years Career Level: Manager (Manager/Supervisor of Staff) Education Level: Bachelor's Degree Summary  The Quality Engineering Manager is responsible for administration of all Quality Engineering functions within the company, including inputs toCAPA, customer complaints, validations (among other Quality System elements), and support to R & D during product realization stages.  The Quality Engineering Manager will also provide leadership, support, and direct management to the Quality Engineering Team, and support to the  Quality Assurance department as required.  Essential Duties and Responsibilities§  Supports, consults, trains and leads quality improvement projects throughout the life cycle of Ascent products §  Customer complaint investigation management§  Lead and assist in Root Cause Analysis/Corrective and Preventive Action (CAPA) projects§  Utilization of statistical analysis and trending (e.g. rejection rate/complaint rate monitoring) to implement process improvements§  Conduct system and process audits§  Provides technical expertise for validations (e.g. IQ/OQ/PQ) and performs them as necessary§  Create, review, and approve Quality System documentation§  Update and present information to senior management and executive team as necessary§  The preceding duties and responsibilities are intended to be representative of the work and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position (i.e. overall support of the quality department as required). Supervisory Responsibilities§  Provide leadership, motivation, support, and direct management to the Quality Engineering Team Qualifications§  ASQ Certification (e.g. CQE, CMQ/OE, CSSGB, CSSBB) preferable§  Excellent written and verbal skills Education and/or Experience§  Bachelor's Degree (B.S.) or Master’s Degree (M.S.) from four-year college or university in an engineering discipline; candidates with a B.S./M.S in Biomedical, Mechanical, or Chemical Engineering are preferred§  7+ years medical device experience§  2+ years management experience within the medical device industry§   Strong working knowledge of FDA/QSR, ISO 13485:2003, Quality Engineering principles,  and quality tools and methods. Computer Skills§  Microsoft Office (Word, Excel, PowerPoint, Outlook)§  Statistical software, e.g. MiniTabWork Environment§  Office environment§  While performing the duties of this job, the employee is occasionally required to stand, walk, sit, use hands to finger, handle, or feel objects; reach with hands and arms; balance; stoop, kneel, or crouch; talk or hear.§  The employee must occasionally lift and/or move up to 50 pounds.§  The noise level in the work environment is usually moderate.§  May be exposed to Hazardous materials. Employees need to consult MSDS in their work area.§  Required to wear Personal Protective Equipment to protect against exposure to Bloodborne Pathogens and chemicals.§  Possible TravelAscent Healthcare Solutions offers a competitive salary and benefits' package with Health, Dental, Short- and Long-Term Disability, Employer-Paid Life Insurance, 10 Paid Holidays, generous Personal and Vacation Time package and a fully-vested 401k plan with a 4% match.    We are an Equal Opportunity Employer. Visit our web site at www.ascenths.com for more information about this exciting career opportunity.  Send this Job to a Friend Ascent Healthcare Solutions is THE leading third-party reprocessor of single-use medical devices. Ascent Healthcare Solutions was created from the merger between Alliance Medical Corporation and Vanguard Medical Concepts, two of the industry's most respected reprocessing companies. Ascent represents close to half of the hospitals in the United States. Our clients are those who are committed to safely reducing their healthcare expenses, which can mean improvements in nurse-to-patient ratios, as well as improvements in available medical technology. We expect to save our clients approximately $100 million dollars in unnecessary supply expenses this year. In addition, we expect that because of our reprocessing efforts, we can prevent 7,000 tons of unnecessary medical waste going to our nation’s landfills annually, a remarkable environmental achievement. We guarantee our clients that we are compliant with Food and Drug Administration (FDA) requirements. More than that, we are committed to providing customer satisfaction and to offering our clients a comprehensive array of quality services. We are proud to be certified by the International Standards Organization (ISO). If you are looking for a great career opportunity, Ascent Healthcare Solutions just might have what you’ve been looking for. Please view our website at www.ascenths.com for more information about us.