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Quality Engineering Manager
Location:
Saint Paul, MN
Description:
Job Description Title: Quality Engineering Manager Department: Engineering Reports to: Vice President of Development Engineering FLSA Status: Exempt, Full-Time Starting Salary: $93K+ Exempt + Potential 10% Annual Bonus Benefits: Full time associates are eligible for benefits the first of the month following 30 days of service. Medical Insurance HDHP, HSA Plan - Employer Contribution of $1,040/yr. High/Low PPO FSA Dental Insurance Vision Insurance Employer Paid Basic Life Insurance Supplemental Life Insurance Employer Paid Short Term Disability Long Term Disability 401(k) 4% Employer Match Paid Time Off (accrued hours, 120/yr.) 9 Paid Holidays EAP Program Fitness Room Summary: The Quality Engineering Manager will report directly to the VP of Engineering. This position is responsible for ensuring the company's development and manufacturing processes, procedures, and standards reliably produce products and documentation to serve our customers. This associate will lead the organization's quality engineering function which is responsible for validations, qualifications, quality plans, and risk assessments. This associate will be charged with leading our quality engineering team to manage quality function aspects of customer projects with complex manufacturing and packaging processes. As a team leader, this associate is expected to develop and organize the team to optimize performance through goal setting, metrics tracking, as well as coaching and development. Duties/Responsibilities include but are not limited to: Responsible for the leadership and development, coaching, mentoring, performance management and work direction of the Quality Engineering Team. Represent Quality team in portfolio management meetings to appropriately assign and projects and drive accountability. Responsible for company's product quality and reliability to meet or exceed customer expectations through quality plans and process validations. Drive and coach team to develop and execute quality assurance strategies for new product development and sustaining business activities. Effectively create and support process enhancement initiatives to maintain an environment of continuous improvement throughout the organization. Provide effective leadership, support, training and guidance to all company associates in support executing to established processes, procedures and standards. Lead company through the changes necessary to elevate the organization to a premier "world class" contract medical manufacturer. Ensure the proper use of analytical methods to trend data from product development and manufacturing perform capability studies, gage R & R studies, create control plans, FMEA, DOE and other quality documentation requested by Innovize customer's and/or required for internal use. Accountabilities: Accountable for ensuring all equipment (IQ, OQ and PQ), process qualification activities and relevant supporting documentation are completed per the project timelines. Accountable for creation of product quality plans. Accountable for projects and project quality tasks. Achieving company product and service quality goals. Timely completion of resolving product issues and corrective actions. Ensure all established training for self and direct reports is current and up-to-date. Ensuring Performance Management processes for all direct and indirect reports within the Quality Team are followed. Achieving associate retention goal within your team (direct and indirect reports). Ensuring all Quality Management System processes are proper and have been reviewed and updated within the last 24 months. Training/Education/Experience: Minimum 8 years' experience managing in a medical manufacturing environment. Experience working in a medical manufacturing or other highly regulated environment. Bachelor's Degree in life sciences, engineering or business, MBA or other relevant advanced degree a plus. Experience with effectively managing performance of a team including training and development. Experience with mentoring on an individual level to improve performance for reaching their career goals. Strong background in regulatory requirements including ISO, FDA, GMP, CAPA. Experience with continuous improvement and Lean Manufacturing. Experience with planning and collaboration with operational groups. Experience with all phases of the product development lifecycle, verification and validation activities. Strong problem-solving skills at both a strategic and tactical level. Proficient PC skills in Mini-Tab and Microsoft Office. Experience using CAD software a plus. Competencies/Talents/Personal Attributes: High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction Excellent communication and presentation skills Ability to develop and manage a high-performance team focused on accountability and meeting and exceeding expectations Ability to lead, influence, create and work within cross-functional team environments Assertive, take-charge, proven manager with a strong results orientation, positive "can do" attitude and a sense of urgency to get things done Ability to read drawings, recognize UL specifications and understand geometric dimensioning and tolerances. Demonstrates an understanding of ISO 13485 and GMP requirements through active participation in training programs and using the information as guidelines in technical writing to ensure ongoing compliance. A thorough understanding of medical manufacturing, its environment and protocol Ability to accurately assess, develop, grow, reward and retain the talent of associates, while having the courage and the conviction to sensitively, professionally, and expeditiously move "C" players out of the organization Independent and risk tolerant Ability to effectively implement and execute Strategic and tactical development and implementation Ability to challenge existing assumptions Speaks, understands and writes English Evidence of Success: Evidence of Success (Must be limited to two statements and must focus on critical HISTORICAL work performance of potential applicants. For an applicant to be considered for the job, they must show "evidence of success" in their previous jobs of delivering the results that are stated here. If an applicant would be hired despite not being able to show a history of this performance, then that item should not be stated here. These should be the absolute top two items that are critical for the selected for hire applicant must be able to show previous work historical success with.) Can show strong evidence of successful product development process validation planning and execution Can show evidence of managing cleanroom and packaging validation and production support activities Notes: This Job Description is intended to be an accurate reflection of the current job as of the document effective date. This job description is not intended to be an exhaustive list of all required skills, duties, responsibilities, or qualifications associated with the positions described herein. The company reserves the right to revise or amend the qualifications, functions and duties of the jobs or to require that additional or different tasks be performed if business circumstances change. Employees are held accountable for performing the duties of their position, as evaluated by documented scorecards and performance management reviews based upon company specified metrics and goals documented in the scorecard for which the employee is made aware and maintains. To view our Equal Employment Opportunity and Affirmative Action Statement, Click Here . Job Posted by ApplicantPro
Company:
Innovize
Posted:
November 15 on ApplicantPRO
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More About this Listing: Quality Engineering Manager
Quality Engineering Manager is a Engineering Engineering Manager Job at Innovize located in Saint Paul MN. Find other listings like Quality Engineering Manager by searching Oodle for Engineering Engineering Manager Jobs.
Quality Engineering Manager is a Engineering Engineering Manager Job at Innovize located in Saint Paul MN. Find other listings like Quality Engineering Manager by searching Oodle for Engineering Engineering Manager Jobs.