Manager, Regulatory/Quality Systems

If there is an interest in this role, please include the answers to these questions in your cover letter.

1.) Does the candidate have experience working with ISO 13485, FDA and QSR? Please explain in detail.

2.) Please elaborate on the candidate's experience in Medical Device Manufactuing?

3.) Please provide the link to candidates LinkedIn profile:

4.) What is the candidates work authorization status?

5.) What is the candidates highest level of education?

6.) What is the candidates desired total compensation? (Please specify base salary vs. commission/bonus expectation)

7.) Where is the candidate located? If candidate is not near the job location, please explain relocation plan in detail (e.g. timeline, relocating with family, selling/buying property)

8.) Has the candidate applied or been interviewed for any role with this company in the past? If so, please provide details.

Manager, Regulatory/Quality Systems

Experience required: 8 Years

Education level: Bachelors degree

Job function: Management

Industry: Electrical/Electronic Manufacturing

Compensation: Up to 130k

Total position: 1

Relocation assistance: Yes

Type: Full Time Employment

SUMMARY

The Manager of Quality and Regulatory Systems will manage quality systems support by developing, implementing, and maintaining current and future product/process inspection and audits. May be responsible for site regulatory compliance and programs, and serve as divisional and Corporate Quality technical expert as required. Foster divisional teamwork within a continuous improvement environment.

POSITION RESPONSIBILITIES

Manages Quality Systems Support by developing, implementing and maintaining current and future Product/Process Inspection and Audits.

Fosters teamwork within a continuous improvement environment and support implementation of global best practices.

Responsible for ESD capability and programs and assuring compliance with and conformance to applicable ESD divisional requirements and commercial standards.

Serves as Site Lead and technical support expert for external regulatory systems audits and customer audits/questions related to QSR and FDA requirements and other regulatory requirements.

Assists with the development and implementation of regulatory policy and procedures compliant with required standards within the site and Corporate, as required.

Develops, monitors and reports on key quality and performance indicators as related to Production/Process audit results.

Stays up to date on latest and future regulatory requirements and quality standards, communicating with the division and corporation on compliance requirements, now and in the future and adjust strategies and processes accordingly.

Champions selected continuous improvement initiatives.

Monitors and evaluates Quality Control functions at suppliers and company facilities in order to assure components and materials meet or exceed requirements as defined.

Develops a quality plan which includes quality control policies and procedures for all manufacturing processes.

Lead the development of SOPs and work instructions and associated quality tools to improve product quality and to increase work efficiency Identifying opportunities for improvement and developing processes to ensure regulatory compliance and process robustness.

Collaborate and influence cross functional peer leaders in order to obtain support for process improvements.

Oversee the compilation and review of organizational Quality metrics to identify potential gaps or adverse trends.

Coordinates corrective actions on in-house and field product quality problems

Defines incoming and final inspection policies. Ensures employees fully trained on requirements.

Drives equipment calibration procedures and adherence to schedules.

Implements Company programs related to 5S and BAM.

Responsible for the development and maintenance of the sites business continuity plan.

QUALIFICATIONS

• General Qualifications to be added to all exempt job descriptions:

• Excellent written and verbal communication skills

• Effective interpersonal skills

• Effective multitasking skills and the ability to take on additional responsibilities as required

• Effective organization and prioritization skills

• Demonstrate high attention to detail

• Ability to work with diverse groups

• Demonstrates discretion, confidentiality, independent judgment and professionalism.

• Ability to work with minimal supervision and guidance, exercising discretion and independent judgment.

• Understanding of and ability to use continuous improvement tools.

• Strong customer service and client focus

• Working knowledge of productivity tools, including Microsoft Office products and WebEx conferencing software

• Additional qualifications for all management positions:

Demonstrated leadership and people management skills including ability to effectively coach and mentor employees at all levels.

Enthusiastic and motivational communicator with multi-cultural experience.

Demonstrates effective customer interface skills.

Excellent interpersonal skills with the ability to interact and influence individuals, internally and externally, across all levels, functions and geographies.

Use of discretion with the ability to gain trust of business leaders and others to discuss and respond to sensitive and business critical issues.

Effective negotiation and problem-solving skills.

Effective analytical, planning and organizational skills.

Collaborate and influence cross functional peer leaders in order to obtain support for process improvements

Solid financial understanding, risk analysis ability, relationship building and project management.

Additional Specific Qualifications for position

• 4 year College Degree or equivalent combination of education and experience as approved by executive management

• 8+ years quality and regulatory experience; 3+ years in a leadership role in a multiple or large site (600+ employees and associated revenue/customer base)

• Possess and maintain technical expertise and knowledge of quality management systems, regulatory requirements and standards, specifically those related to business sector requirements such as ISO, QSR, FDA, etc. as applicable to contract manufacturing of electronic devices

• Ability to interpret, understand and communicate regulatory requirements as applicable to the Division, serving as topic expert as required in support of the corporation

• Capable of training regulatory and quality system requirements, concepts, auditing methods and quality procedures within the Division to support the Corporation, as required

• Collaborate and influence cross functional peer leaders in order to obtain support for process improvements

MUST HAVE

• 4-year College Degree or equivalent combination of education and experience as approved by executive management
• 8+ years quality and regulatory experience; 3+ years in a leadership role in a multiple or large site (600+ employees and associated revenue/customer base)
• Medical Device Manufacturing Experience
• Possess and maintain technical expertise and knowledge of quality management systems, regulatory requirements and standards, specifically those related to business sector requirements such as ISO, QSR, FDA, etc. as applicable to contract manufacturing of electronic devices
• Ability to interpret, understand and communicate regulatory requirements as applicable to the Division, serving as topic expert as required in support of the corporation
• Capable of training regulatory and quality system requirements, concepts, auditing methods and quality procedures within the Division to support the Corporation, as required
• Collaborate and influence cross functional peer leaders in order to obtain support for process improvements
• Must Be US Citizen