Senior Manager, Quality Engineering

Position Summary:

• The role’s 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:

1. ( 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.
2. ( 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.
3. ( Safety ) – Be vigelent and the champion for the health and safety of the team and environment.
4. ( 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.
5. ( 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.
6. ( Manufacture ) – Investigate and resolve quality issues related to manufacturing and releasing of product.

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   ( 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.

    

8. ( Investigate) - Evaluate, develop, and improve manufacturing processes by studying product and manufacturing methods. Investigation and be the team leader with regard to CAPA’s and managing root cause analysis and fishbone activities related to material and/or manufacturing processes.
9. ( 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.
10. ( Participate ) - Participate in the development of long-term strategies for materials and manufacturing process improvements.
11. ( Communicate ) - Provide regular communications on service level support, manufacturing and engineering activities to ensure product quality and delivery.
12. ( Customers ) - Obtain and analyze data on key metrics and support manufacturing yield to deliver to customer demand.

Studies, Experience, Skills and Qualifications:

• BS is a discipline such as Biology, Chemistry, Manufacturing / Mechanical Engineering is preffered
• Must have 10+ years of management experience and proven leadership.
• Preferred 10+ years of Non-Conforming investigation writing.
• Preferred 10+ 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 cross-functional 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 problem-solving skills.
• Must have demonstrated abilities of leading, mentoring and professionally guiding a team of people to defined objectives.