Job Description Summary

Job Description

Job Description

-Supervise employees and quality activities pertaining to the production of products and/or quality systems and processes in - and with quality/technical knowledge of -2 or more production areas, depending on the complexity of the areas, in addition to conducting performance reviews, including resolving performance issues.

- Accountable to ensure staff is appropriately trained to perform assigned work

- Accountable for productivity and quality metrics of staff, and provide regular progress reports and quality metrics to management and cross-functional stakeholders

- Lead improvement projects, partner with engineering on investigations and/or corrective actions, perform non-conformance investigations for review with engineering, assures documentation content is valid.

- Oversee team performance metrics.

- Document owner for applicable quality procedures.

- Provide quality approval for documents or products manually or through ERP.

- Support product/process transfer projects to assure compliance with procedures, as well as facilitation required in the transfer.

- Other incidental duties

Education / Experience

- Bachelor's Degree in related manufacturing, quality and/or product development engineering.

- 2 Years of previous related experience with full responsibility for all personnel including hire/fire authority and handling all aspects of employee relations in manufacturing, quality and/or product development engineering.

Required Skills

• Experience leading multi-cultural teams with cultural sensitivity

• Project management experience

• Proven expertise in Microsoft Office Suite with working knowledge of Enterprise Resource Planning (ERP) systems

• Experience working in a medical device industry, preferred

• Excellent communication and interpersonal relationship skills; possessing strong collaboration skills in partnering with cross functional stakeholders in order to achieve objectives, as well as mediating differences to achieve consensus

• Ability to read, comprehend, write, and speak English and Spanish

• Full understanding of quality procedures related to all stages of own area of responsibility

• Ability to supervise/lead employees in a manufacturing environment

• Full understanding of all aspects of processes and equipment used in assigned work

• Demonstrated ability to supervise teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR

Required Skills on all aspects of employee relations

• Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing

• Knowledge of Lean Manufacturing concepts, SPC, Process Map, DFMEA/PFMEA and Six Sigma.

• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment

• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Required Skills

Optional Skills

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Primary Work Location

Additional Locations

Work Shift