Manager Quality Engineering
Manager Quality Engineering
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Position Summary:
- The roles primary function is to provide leadership to a team of engineers that are responsible for the daily support of manufacturing as related to the quality of raw materials finished goods suppliers customer complaints and corrective actions.
- The responsibilities include both doing and leading a team that performs investigations determines root cause develops and writes justifications for the disposition of raw materials and finished goods investigates customer complaints and proposes solutions.
- The role reports to the director of manufacturing and will be responsible for clear and concise communications leadership skills that includes the ability for critical thinking detailed evaluations focused decision making coordination of a team delegation of tasks and decisive leadership for the purpose of supporting the daily manufacturing of medical devices.
Main Accountabilities:
- Management Actively manage the day to day functions of a team. Determine and list task prioritize and delegate actions ensure schedules are respected and achieved deliver results that are on time and to budget.
- Leadership Actively support and mentor a team. Take ownership and responsibility for leading a team through challenging and emerging issues. Be the leader that actively manages situations defines and implements plans for the purpose of resolving issues.
- Safety Be vigelent and the champion for the health and safety of the team and environment.
- Regulations Take ownership to ensure that decisions and actions comply with Good Manufacturing Practice (GMP) ISO and all applicable Quality Management System requirements for the manufacture of medical devices.
- Business Through decision making and delegation support the daily manufacturing and release of product for the purpose of growing improving and sustaining the business needs of the company.
- Manufacture Investigate and resolve quality issues related to manufacturing and releasing of product.
- Investigate) Evaluate develop and improve manufacturing processes by studying product and manufacturing methods. Investigation and be the team leader with regard to CAPAs and managing root cause analysis and fishbone activities related to material and/or manufacturing processes.
- Collaborate Collaborate with supporting departments such as: Supply Chain Engineering Incoming QC Final QC Manufacturing Quality Assurance and Purchasing to identify and lead material and/or finish good related investigations and issue resolution to ensure optimum manufacturing processes.
- Participate Participate in the development of longterm strategies for materials and manufacturing process improvements.
- Communicate Provide regular communications on service level support manufacturing and engineering activities to ensure product quality and delivery.
- Customers Obtain and analyze data on key metrics and support manufacturing yield to deliver to customer demand.
Suppliers Obtain and analyze data on key metrics for the support of raw material suppliers to deliver quality materials used in the manufacturing of finished goods.
Studies Experience Skills and Qualifications:
- BS in Biology Chemistry Manufacturing / Mechanical Engineering prefered.
- Must have 5 years of management experience and proven leadership.
- Preferred 5 years of NonConforming investigation writing.
- Preferred 5 years of experience working in an FDA Regulated Environment.
- Preferred working experience in a high volume automated manufacturing setting.
- Preferred prior knowledge of FDA/ISO regulations and process validation.
- Must have demonstrated ability to collaborate across levels of management in a crossfunctional team environment.
- Must have functional knowledge of Microsoft Office (Word Excel PowerPoint and Outlook) required.
- Must have demonstrated clear communication and interpersonal skills.
- Must have demonstrated analytical and problemsolving skills.
- Must have demonstrated abilities of leading mentoring and professionally guiding a team of people to defined objectives.
Required Experience:
Manager
Employment Type
Full Time
