Job Description:

Designation: Quality Assurance: Assistant Manager QMS/QA (Vascular Accessories)

Reports to: Manufacturing Head

Location: Dehradun

Key Responsibilities:

Supervisory Responsibilities:

• Guide the QMS team towards implementing the procedures efficiently according to the QMS flow chart / Procedure manual
• Plan tentative Schedules for implementation of QMS at manufacturing units and to conduct Internal QMS audits at regular intervals in manufacturing units.
• Guide the Auditors for Proper audits, accurate reports & conduct closing meetings at Factory after completion of audits and review the findings along with FM/PM/Department Heads.
• During Audits itself based on audit findings ensure the factory HOD initiates the root cause and corrective actions from respective auditees/Process Owners.
• Educate factories to analyze the nonconformity and identify the frequently repeating NCs and ensure the CAPA is effective.
• Review factory wise/department wise comparative analysis prepared based on audit findings before submitting the audit feedback for MRM.
• Induction training (QMS awareness) to all including freshers, newly joined employees.
• Work on new requirements /Changes initiated by any customer with regards to process flow/procedure/formats, fulfil the requirements in consultation with HOD.
• Shall identify flow for each process & ensure documented in the QMS procedure manual/flowchart.
• Shall ensure the procedures are defined to prevent unauthorized changes in procedures.
• Responsible for change control.
• All QMS activities related to vascular accessories product.

Required Skills/Abilities:

• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• Excellent organizational skills and attention to detail.
• Excellent time management skills with a proven ability to meet deadlines.
• Strong analytical and problem-solving skills. (Usage of Root cause analysis tools like 5W, 7 QC tools etc.)
• Strong supervisory and leadership skills.
• Proficient with Microsoft Office Suite or related software.
• Excellent knowledge of ISO13485
• Six Sigma knowledge will be added advantage

Education and Experience:

• Bachelor’s degree in Engineering, or field related to the products being produced required.
• 6 to 8 years of experience in related field required with supervisory experience a plus.